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Medtronic Sprint Fidelis: "I'm beginning to wonder if any of their leads are worth a crap."

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Wyoming, MIAt first, Lisa Kraft's story sounds like a classic Medtronic Sprint Fidelis failure. She had a Medtronic device implanted last fall; early this year, one of the leads failed, and a month later was found to have fractured. Now she's trying to decide what to do: Have the lead replaced? Leave the device in place and hope for the best? Get rid of it altogether?

The story diverges at that point, however. That's because she's not talking about a Medtronic implantable cardiac defibrillator (ICD) with defective Sprint Fidelis leads that are known to be subject to fracturing and have been recalled; she's talking about a Medtronic InterStim II implantable bladder pacemaker that's supposed to help control bladder problems such as chronic incontinence.

Fidelis SurgeryThe InterStim II received fast-track supplemental approval from the federal Food and Drug Administration (FDA) in July 2006 as an upgrade to the earlier InterStim. Among the modifications noted in FDA's approval announcement was... thinner leads. Sound familiar?

Kraft (not her real name pending possible legal action) had an InterStim II implanted in November 2007. The device uses four thin leads that stimulate the sacral nerve to help with bladder control. The frequency of stimulation can be controlled via a range of different programmable patterns. Kraft, who works as a delivery driver for DHL Courier, says, "I've had a bad habit of wetting my pants," hence the InterStim II. She hoped that it would solve the problem.

In mid-January 2008, Kraft went in to her doctor to have the device checked. At that time, she says, she was told that the main lead was not working. "One month after my surgery and my main lead is already not working," she says. "They said it might be because it was in a fluid pocket, whatever the heck that is, and it's no big deal." A month later, she says, "I went in again and they said it was fractured and had to be removed and replaced.

"They said the lead was cracked, possibly from a pressure point. I'm a skinny lady and I drive and bend a lot, so they're thinking that between those two things, that's why it broke. Now they're saying that even if they do fix it, there's no guarantee that it'll work again. Meanwhile they billed my insurance company $45,000 for this thing and I didn't get two months' use out of it. I'm getting help from the state, which is helping me out through Medicaid because I was so far behind in my bills that they picked me up. I'm maxed out with my regular insurance. They only cover so much a year.

"This doctor's big on this thing; she implants them every week on Thursday, all day long. She's put in like a hundred of them. She said that another girl just had a problem with hers, and she's a school bus driver. But my god, bending and sitting is an everyday thing in any job—just bending and sitting!

"They knew all about my job and my size before they even went forward with this. Normally, you go in on Thursday and you can be back at work on Monday, but they kept me out of work for four weeks because of my job; she wanted to play it safe before I went back to work. I had to take four weeks of no pay at work, too. They don't give you unemployment if you're not available for work. I couldn't get workers' compensation either, since it wasn't a work-related issue.

"Before you have the system put in, a Medtronic rep explains everything to you, but once it's in it's just you and the doctors; the Medtronic rep disappears. I called Medtronic and said I wasn't happy about it. I asked who was going to pay for taking it out.

"They say it's not up to them, it's a medical problem and they'll bill it to my insurance. By the time this is all done, I could be out $100,000 or more. Nobody's really guided me about what to do. If it's a bad system, I just want it taken out. I'm a 48-year-old woman and I can't afford to be missing work.

"Now it's more or less non-functional. I called the Medtronic lady because nobody was getting back to me about whether to fix it, keep it in, or take it out. My dad said to turn it off, but she said to go ahead and keep using it, but the leads need to be replaced. They say the batteries are supposed to last three years, but God knows if that means I'll have to be cut open every year and have a new battery put in.

"In the meantime, I'm walking around with this dead thing in me and my doctor says, 'Well, if we fix it and it breaks again, we'll know it's your job.' Am I supposed to change jobs because of this? Well, I live in Michigan and there are no other jobs. Believe me, I've looked.

Kraft visited LawyersAndSettlements because she was familiar with Sprint Fidelis lead failures and hoped to find answers about the InterStim II leads. "A friend of mine, her father had one of those put in for his heart and he just had to go in and have a lead changed," she says. "I was wondering if they're the same leads. They're trying to blame this on my job and my size, but I'm beginning to wonder if any of their leads are worth a crap.

"I've contacted my doctor and asked for an itemized bill so I can see how much this whole system costs. It's a real money maker for them. All my doctor does from 7:30 AM to 7:30 PM every Thursday is whip these things in. Medtronic isn't going to let it out that there are troubles with this thing and it's not as great as they're making it out to be. Meanwhile it's my body and this thing's bumping around inside me.

"Maybe somebody knows something and knows where to direct me. I'm just that kind of a person—I don't like to get screwed over."

READER COMMENTS

Posted by

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I'm 55 years old, I had the Bladder Stimulator put in April 18 & May 11,2016. Since, the trial I had major problems and my final surgery, my life changed to my worse nightmare.Everday, is a new challenge, the side effects, pain, mentally, physically, urinating constantly, sleep deprived and etc. As os July 24, 2016 I shut this garbage off. Next I have demanded to have it taken out. My advice, why would any doctor put this device of Medtronic into our bodies? Known of ALL these red flags, defects,deaths, bad side effects that makes my body worse. Lord please help US all, who have these devices.

Posted by

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I had a Medtronic Stimulator temp put in on June 10, started tracking my voids leaks changes of clothes and the urgency level. The highest urgency level being a 5, I never came lower than a 4, was still wetting myself and having to change clothes. The only thing that improved for me was the number of times per day I went. Yay for me!! I still didn't make it to the toilet more than 50% of the time. Everyone at Medtronic says that I've made an 83% improvement but I say it failed miserably!! I can't even get the urgency any less than a 4, then it was explained to me that the temporary implant is really only good for the first 2 days-anything past that and the leads could have moved. So, anything past 2 days is a waste of time. Thank you Medtronics for making me feel like more of a freak than I did before!!

Posted by

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I have an interstim implant. The trial with the wires on the outside worked , however once implanted it never gave me ANY relief. Has anyone been contacted to commence a class action suit? I received a survey from a local hospital, somehow they tracked me down and wanted my opinion on the product. Wrong person to ask.

Has there been any new advancements to help those with incontinence? Medications, procedures etc?

Posted by

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After having a herniated disc and a very complicated surgery to remove what came out, I went through many different things to try and alleviate the pain, including physical therapy, injections, medications, etc.... I was referred to an anesthesiologist to get injections, there I was introduced to a couple of guys that identified themselves as representatives of MedTronics, between the Dr. and these representatives they convinced me that I might would benefit from a Neuro-Stimulator device that could help with the pain. I was told that they would be available to adjust the device. I did a 6 day trial which was okay, it just felt like butterflies dancing up and down my leg, however it was positional, I was told once I got the permanent one it would set up and not be positional. I went ahead with the surgery allowing them to chose a neurosurgeon, they set me up with a different one than my original Dr. who I wanted to do it, stating that he was too busy and it would take too long to get an appointment with him. I allowed this. The new neurosurgeon was a barbaric idiot, he showed out prior to the surgery, he threatened to cancel my implant surgery because the nurses were not working fast enough for him, because he was working so fast at putting these devices in the pre-op nurse had not had time to restock her work station, she apologized to me and told me she would have to put a "nail" in my arm for the IV, then he demanded I have a urinalysis prior to the surgery, even though I had completed my pre-surgery testing and had voided before getting into the bed, she told me that I would either have to void or she would have to cath me, I was able to void by standing up and just pushing. I went into surgery having just met him and with sedation on board for the first time, although I had heard him showing out. I have to tell you had I been able to leave I would have and I wish that I had told them to cancel the surgery. They had explained to me prior to the surgery during the pre-op testing that I would need to stay over night for pain management, they had a list of all of my medications. I was told that I would have a 1 inch incision on my back, and a 2 inch incision on my right side, I came out of surgery with 8 inches of cuts, even though the dr. had a list of my medications and my allergies I suffered greatly because the Dr. prescribed pain medication that was much less than what I had been on at home, along with a shot of morphine every hour which I had told them I was allergic to. I was so sick, the morphine made me nauseous and throw up, the 5 mg of loratab was very inadequate for the pain I endured, my back and rib cage area had such spasms I couldn't even lift my head up to drink water. The nurses refused to even call him to get the medication changed, it was 24 hours of pure hell, then a 2 1/2 hour ride home the next day in which my husband had to stop 5 times for me to throw up because the pain was so bad. I was told the day of the surgery that the neurostimulator would only be turned on after 2 weeks, so I went home with the implant not even being on. It was a nightmare that I do not care to repeat. I have seen the Medtronics reps. 3 times in the last 18 months, 1 to turn it on, and 2 times to try and adjust it. They refuse to work with me, they refuse my calls, they have abandoned me with this 100 thousand dollar piece of equipment in my body that does not work. I was told prior to the surgery that the only thing this would keep me from getting was an MRI, not true. I cannot have ultrasound therapy which helps a lot, I cannot use a tens unit anymore because it will interfere, I cannot go for massage therapy for fear it will damage the leads or turn the battery. I am having this thing removed next week, by my original neurosurgeon. He tells me that his practices has quit working with Medtronics because the after care is terrible and their devices are not working properly. Lord have mercy, I have since found out that I have a 40% blockage in my LAD and this is dangerous for me but it has to come out, it is keeping me from getting treatment for bladder/bowel issues that have been going on since the implant, I have no idea if the wires are causing the trembling and shakiness in my arms, the going to sleep in my arms. I pray that I can find an attorney to deal with this for me because this has cost us so much and we are on a fixed income, the travel alone for treatment is 2 1/2 hours, plus we have to have at least 1 meal while we are there. Now this second surgery which means I will be away from home at least 2 nights, 1 of which will be in a motel. I would not ever advise MedTronics for any device, I am very angry and bitter about being lied to, had I known prior to this surgery that the people I was talking with were sales representatives I would have never had this surgery done, NEVER. I never deal with a Sales Representative unless I initiate the contact. I just recently learned that they are sales representative and not trained medical personnel with MedTronics, now I am embarrassed because a salesman has seen me naked because they have to be in the OR when you get the stimulator. Please do not do this! I have not met 1 person that has had any luck with this treatment option.

Posted by

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I came across this site looking for any information about defective ICD's that cause them to electrocute people. I had my third Boston Scientific ICD put in last March, 2015. I developed an infection after and high fever. That's when I started feeling like I was constantly being electrocuted. I can not get any Dr to take this awful thing out. It has caused numerous side effects, including my BP to be dangerously high. I have never had problems before with hypertension. BP meds do no good since it is my body's response to being constantly zapped. I also have other side effects that have ruined my life-I now have no life. Has anyone else had trouble with their ICD? I can't understand why people such as Dr's would inflict this kind of torture on their patients. They will not take it out. The hospital and Dr where it was put in won't even return my calls or see me.

Posted by

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I had my stimulus put in my back for chronic leg pain and with in a week I went back in because the battery was getting hot so went in and they found I had staff infection around the battery so was in the hospital for 3 weeks and they took the battery out and cleared the staff infection up and went back home 3 days later my back swelled up when back in the hospital and they said now I had staff infection the leads in my spine so they treated me for staff and removed the leads medtronic never called and never heard for the again now I still have the Chronic leg pain and back pain I'm now Enrolled in pain management for my back pain thank medtronic I would never Recommendyour my stimulus to any one it Ruined my life

Posted by

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Hi every one my name is Brittiany I'm 26 years of age I have been having my bladder stimulator in since January 23 2015 it's the worst feeling ever I just stop peeing due to cancer got this put in and still really can't go on my own still have to ear a Foley catheter sometimes self cath or take flomax which is for men I hate it I hate it I hate it I'm always in the er and even when I go they either never heard of it or don't know what to do about it god is the answer here just pray

Posted by

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My implant was causing me pain in the groin and where the implanted device was. The device was moving around in the scar tissue. The doctor said the implants some times move around in the scar tissue. The lead's would give me a jolt when I would squat down and then they started to give me pain like a pulled muscle in the groin. On Vetrains day this year I had the device removed and the lead's broke off and now are stuck inside me.
If anyone knows of a good lawyer or case against this device please let me know. Thank You

Posted by

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I also had the interstem device by medtronics
What a nightmare! Put in in july of 2013 and demanded it be remived in December of 2014.
I had a bladder infection nearly every 15 days and was put on antibiotics and am now allergic to several antibiotics. The antibiotics screwed my immune system leading me to contract hashimottos disease!
The device surfaced to the top a month after placement so another surgery to bury it deeper only to have it flip over. Then another surgery to right it. In the meantime and several settings with no success, the device shut off or the interen shut it off--who knows but went for a couple of months with it not working. Medtronics rep was very mad. Got it working again only to have it surface back to top and then flip again and begin shocking me even when I wad asleep!
Had to just turn it off. Then dr suggested taking it out and trying it on the left side. I said just take it out, it was not working for me. I was then informed it was a $30,000 device. I should respect it and let it work!
I demanded it out and said it was causing the bladder infections but was told that was not possible.
Had it removed and guess what--it was massively infected so they had to take it out and would not have been able to move it to the left side. Hmm--a year and a half if total pain, tears and frustration!!!!

Posted by

on
My heart is saddened reading these comments. I was conned into getting this implant after a Dr tore all of my insides during surgery. I was left with urine and bowel incontinence.No meds helped so i moved forward with the interstim. It never worked so i had it removed. My everyday life consist of nothing but pain. Hip, spine,leg, groin and thigh pain. Hip pain is so unbearable at times that it prevents me from walking. My urologist says even though my pain is at the implant site its not the reason for the pain.These folks are full of shit.!! I just turnt 34 and have 4 children i cant do anything for but love because of this. Instead they have to do for me. I pray you guys never give up because im not. Im gonna fight this one out with my attorney in court. No one deserves to go through this torture!!!

Posted by

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I feel for everyone who is going through the nightmare of having a stimulator still in there body. Mine was done in the summer of 2012 for the treatment of severe lower back,knee and ankle pain. The trial unit was only in for two days before the permanent unit was installed. It only took seven days for the worst part of my life to kick into high gear. First I ended up in the emergency room for 8 hours and then an hour ride in an ambulance to a behavioral hospital. The leads from the trial unit and the permanent unit were not the same. The leads in the permanent unit were stronger and I could feel the effects of them from my fingers to my neck and down to my foot. I could not turn the unit low enough to not feel the shocking effects. Just the thought of having it my body and not being able to turn it off sent me right out of my mind. After the doctors in the emergency room could not treat me, because it was to soon after the surgery to implant the unit they sent me to a hospital that they claimed would help me get my pain under control. The doctors never informed me it was a behavior hospital so once I was checked in i was stuck there and not able to get out. Finally after 24 hours of complaining my wife and mother got me checked out. Within the next week I had the unit removed. The pain medications I take now help somewhat but the life long effects of that horrible stimulator will stay with me from here on out. Since then I have had a cage put in my lower back along with several disc fusions, more knee surgeries and another foot surgery. I know have a constant burning sensation in my right thigh from my hip down to my knee. I can't even stand for the sheets to rub against my leg and i have a constant pain where they cut the vertebrae to install the wire leads. Before anyone decides to go through this first ask yourself if you think you can handle having this foreign object in your body. I have a total knee replacement,a wire cage in my lower back and several other metal objects in my body and sometimes it gets a little overwhelming. The mental stress it brings is definitely not worth it. My thoughts and prayers go out to anyone who is caught in this position.

Posted by

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After ready everyones stories i dont feel alone anymore. I am on my second implant the first time I was having electeical shocks, right hip pain to the point i could barely walk or sit without pain my bladder was constantly hurting. I turned the implant up and it just buzzed around in my hip and i could feel the implant right under my skin. The pain went down my right leg and around to my back and around to my stomach. Went to the dr who put it in and he just turned it up and said see how this works. I had the implant off and ask him to turn it back on cause i did have my antenna and he stated he did t k ow how it worked. I had since moved and Went to a dr where I was living and she said the implant had come out of the pocket it was in and several lead wires were broke. A new dr put in another implant in June of 2014 it worked fine for awhile-since then I moved back to the area where the first implant was done. I began having problems with the implant not helping my bladder he adjusted to a different setting worked for a little while. Since the second implant was put in i have been back to the dr anout 10 times due to bladder pain and he never once hooked me up to a master machine to see if something was wrong with the implant. For the last four months i have had severe pain in my right hip that again goes down into my right leg around to my back and stomach. My right knee hurts. I can barely walk because of the pain in my hip. My bladder is hurting really bad and today i have the urge to pee and i cant the last time i have been able to pee was 12 hours ago. I called the dr back again this last week and told them their adjustment wasnt working and my right hip was hurting real bad and bladder was still hurting. When i went to see him he asked me for my setting device and i gave it to him he asked where the antenna was i said you dont need the antenna that all you need to do is put it up next to the device in my hip and he said I didnt know that-this is the PA who is reaponsible for my care and he didnt know that. Well he changed my program to see how that did and it didnt help so I called back and told the nurse and asked her if they had the devise that would sync with my device to see if it was the device itself and she said they didnt have it- now mind you this is a big clinic with 5 urologists. I told them i wouldnt be back i would find a dr who had ths proper equipment to see if it was the implant as it is the same symptoms as before. Today is Sunday and I have an appt Wed. I want them to take it out i cant handle the pain anymore. If there is a lawsuit count me in. I would not recommend anyone getting one of these implants. Thank you. PAULINE

Posted by

on
I received my Interstim implant around 2000 when it was enthusiastically recommended by my urologist. I was in desperate pain from severe Interstitial Cystitis. My doctor had become exasperated that I did not feel comfortable to continue taking methadone, which me me a non-person, completely out of it. So The State of Texas through Texas Rehab, paid for the procedure. It was NEVER really effective. My big toe always curled and moved up and down if I turned the device up. I NEVER felt it in my bladder. When the battery died, I left it alone, where it still sits like an oddity under the skin of my buttocks. I found out a year or so ago, through My urology clinic at Methodist Hospital in Houston, that the device was in the wrong place.

Posted by

on
I had my Medtronic interstim implanted on August 12 2015 mainly for my IC symptoms of pain and urgency. I told my doctor at the time that I could live with the frequency and urgency, but the pain was more than I could handle. He said that only 20-30 percent of IC patients had relief from pain with an interstim device, but any relief from frequency, urgency or spasms could help with the pain. At the time, my pain was so debilitating, I was willing to try anything. Well, that was the worst thing I could have done. I did the trial, which only lasted for 24 hours for me because the wires came out. I did notice that it helped with the frequency, so I had him do the implant. Today is October 16 and I have been in a terrible flare up since that surgery. I thought that maybe I had the device turned up too high because I was having such terrible bladder spasms, so I turned it down a little. Since I am in pain management, that doctor had given me something extra for pain just for the procedure. A week after the procedure, I contacted her and ask if she could give me something more until I saw her again. She got in touch with my urologist and he told her that any surgical procedure would cause a terrible flare up. Wow, he didn't tell me that. Regardless, the extra pain meds didn't help at all. I even tried extra bladder installations with no relief. Finally I turned it off and told the PA at my urologists office that I had it turned off to see if it was just a bad flare up or if it was the device. A week later I turned it back on. I began to have terrible ankle pain, knee pain, terrible, terrible low back pain that I have never had before and I felt like the device had been set on fire underneath my skin. Any movement I made felt like a knife stabbing me in the back at the implant site. I can also move it around when I rub it with my hand. It is the worst type of pain I have ever experienced. As for the urgency and frequency, it may have gotten a little better, but now I have to strain terribly to empty my bladder and it takes me so long in the bathroom that it is a little embarrassing. People who have IC have so many problems and pain as it is. Then to add this on top of it. I have an appointment to see my doctor and plan on trying to have it removed. Any class action suits, I want to be in on. This has been a terrible 2 months considering that having IC is awful as it is. I feel pretty lucky that I have found this information so that I can keep it turned off. Even so, the burning pain under my skin makes me wonder what damage it has caused.

Posted by

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I had my medtronics implanted in May 2014 for fecal incontinence. It never worked, so I turned it off. After implantation, I started having severe pain in my sacral area. I quit walking and standing for any length of time. After about a year I was able to walk again and no longer had pain. A few months later the wire had floated to just above the butt crack. I believe this wire caused my "year of hell".

Posted by

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Wow! I don't seem to be alone here. I have been calling the doctors office since May. This is my second devise since 2012. Other doctors will not see me for this issue. Makes me wonder what the heck is going on! And why hasn't a lawyer made some kind of attempt to get these devises taken care of?
My stem is once again sticking out (still under skin but can see it & feel it)!!! Feels like my insides are falling out!! And now on top of it..........it feels like a bladder infection!! Sex is also an issue. I have had a hysterectomy so I should not bleed. Wonder if we will get any relief or help from someone before we can't get out of bed from the pain.
I pray for all of us to receive the help we need!,

Posted by

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I had the interstim put in November 2014.my health has declined rapidly.the doctor that put mine in has left our town so its hard to find new doctor to review all my problems i have not been able to work since a month after the surgery.I DO NOT RECOMMEND FOR ANYONE TO HAVE THIS DEVICE PUT IN .The side affects are so bad and So real.I live with constant pain everyday to the point not sure life is worth living anymore.If anyone has filed a law suit against them i will be happy to give my opion and medical records to support your claims.

Posted by

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I have had the Medtronic Implant since 2005. I was told that the implant battery had gone bad after only two years and had to have another surgery to replace the battery. The leads went bad in that unit another two years later. The unit does help with the problem of having to urinate frequently but starting with the second implant I had a lot of issues with leg...toes curling...cramps and constant knee issues.

I have had my current implant for awhile now with a lot of success. However I'm still having knee issues. For the last month my lower back has been in tremendous amounts of pain. I have been seeing a chiropractor and a spinal doctor and neither can figure out what is causing the pain since I can't do an MRI. The x-rays have been causing them to scratch their heads. The pain is getting worse so I'm hoping that during my next check up with my urologist some answers can be given or at least direction on what to do. I'm 37 years old now and got the implant when I was 26 so I got it fairly young and am hoping I have not gotten any permanent damage.

Posted by

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I had a medtronics Stimulator implanted as well. The medtronics rep I had/have is awesome. I have her number and she gets back with me whether she can help or not. The leads go into my head, the Stimulator is on the right side of my neck and the battery pack is right above my right butt cheek. I've had mine a little over 2 yrs. It was implanted for migraines. At 1st it was the best thing ever. In the past year things have gone down hill. I went to the neurosurgeon that implanted because I was having lower back pain, pain in my right hip and down my right leg. He ordered a milogram to see if the battery pack was causing the problem. He told me it wasn't the battery pack nor any disc in my lower back BUT HE'D DO SURGERY (seriously what are you doing surgery on???). Needless to say I left pissed. About a month later I got papers on my disability and the notes from the neurosurgeon were in there stating I had something wrong with my lower back and he'd do surgery but I'm obese. Anyway, I have been running fevers, white blood count is high and the doctrs can't figure it out. Well I developed sores on the battery pack and was told it was shingles. Now while laying on my right side I have tingling on my right side that wraps around my stomach. I have suspected the Stimulator but now this site really makes me believe it is definitely the Stimulator.

Posted by

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I have a question I am hoping for answers to. I had neuro stims put in my back July 10th and the battery pack installed in to my gluten region and have since been struggling with severe sharp pain in my right hip that radiates down my leg and the battery continually "flips" which is extremely painful. I am really wanting this removed from my back as I feel this has made the situation worse instead of better. Anyone have any ideas because not sure I can handle it (the battery pack) flipping anymore it is excruciating and feels like a large baseball sticking out my lower back. HELP!!!

Posted by

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I got the Metronic Interstim Implant in 2004 and I have since had to have another surgery for the battery replacement. I have been having alot of medical problems since getting this implant in 2004. I have had the low back pains and shocking pains that run down my legs which the doctors thought was from diabetic neuropathy but none of the meds have ever helped with it.I have spent so much time and money at doctors and on medicines for the body aches and pains with no real answers. I have been through over 20 surgeries in my life and I am sure that most was related to the interstim. I have had nausea so bad since 2008 that it's got to where I am taking nausea meds everyday and not able to even eat at all some days. I am about to go into surgery to get this implant removed finally so I can get a MRI and hopefully see what all is wrong. I wish I would of known all this was going to happen in 2004.

Posted by

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I am only 35 year's old. Right before my 19th birthday I was a passenger in a head on car accident that I almost didn't recover from. I am on both Medicare and Medicaid. In the accident, one of my injuries was that I had broken the right side of my pubic symphis bone in my pelvis. It wasn't until 2006 after failed medication trials that I was sent to a urology specialist in Seattle who had diagnosed me with painful bladder syndrome. I had the trial run with the older model of the interstem so a permanent one was placed. I did not feel for almost 7 year's the tapping that I was supposed to have felt, however, the first implant was a complete success. In 2013, the battery was discovered to be almost dead so I was scheduled to have the battery replaced. Instead my surgeon replaced the whole unit with an updated model. After the surgery, it was then I noticed the tapping that was supposed to have been their all along, except it wasn't were it should have been and I still continued to have the same results associated with the original implant. Less than 3 day's after my surgery I developed such neuro pain and some bleeding issue's that I wound up in the local ER, I was unable to sit, stand, lay down or anything. I was told after the fact that my body had literally encapsulated the old implant and my surgeon had difficulties getting it out. I wasn't told if she had given me a spinal block as a result to counteract the possible neuro pain from the removal process. It took a heavy dose of another pain medication on top of what I'm on regularly for pain to get the intense neuro pain under control.

Very recently I have started having falling spells, an increase in my hemiplegic migraines, systolic BP issue's only, fever's and myclonic jerking in my left arm along with vision problem's, which my vision I've never really had an issue with as well as my BP. Today (18th) I finally was able to get into see my surgeon/urologist and after diagnostic testing they discovered my implant to not be functioning correctly. They couldn't get it up to 1 without me being in severe pain in area's I shouldn't have felt it. For over 6 month's it's been a non stop recommendation of turning my new implant off for a long period of time and then turning it back on, etc. Another thing that I have noticed since the original one was placed was non cancerous tumors occurring which I've had to have removed due to their locations, I have had to have one removed from the back of my right arm which turned out to be fat nacrosis (premature dying of fat cell's)...one removed from the bursa sack of my left knee, one from my abdominal wall (last year), one from my right anterior part of my shin (we're now their is a more dense tumor in its place). I also have a non cancerous tumor in my left breast that is not small and a small tumor to the right of my lower lumbar vertebrae.

My hemiplegic migraines (neurological migraines) have gotten more frequent to the point they have caused me to have sensory overload (ringing in my ear's, taste and smell disruption, visual impairment, balance issue's, memory loss where I'm forgetting day's/time/etc.)

Since shutting the implant off I am no longer experiencing a sporadic shock that starts in my hip and travels into my groin and makes me stumble. However, I'm experiencing pain around the implant and to the right of my lower vertebrae close to it. I was also informed today that I am safe to get an MRI on my head as long as it does not go below the neck because of the neurologist are wanting to see if their's more going on with these rare migraines. I was always told to never have an MRI due to the magnetic affect on the battery so I'm a bit confused by this.

It is up in the air if the implant caused my fall's which led to the implant not functioning or the fall's led to the implant not functioning.
I have always had sporadic perephial nerve issue's with my left arm but I have noticed an increase in that as well. As well as my sleep has been extremely difficult because it feels like I am unable to shut off my brain processes.

I am seeing a neurologist at the same hospital where my urologist is located and my urologist at this time wants to focus on what's happening and occurring in my head, however, she did inform me I would have to undergo another procedure to fix the problem which can only be performed under general anastasia since I fall into a rare category where I do not respond to conscious sedation at all.

As I informed their office today, when it work's, it's a miracle, however, it has been rough since 2013. I am fortunate to be dual covered to cover the costs, however, I am working towards the goal of getting off social security after graduating from college last year with my Bachelorette degree in Criminal Justice and with a 3.47 GPA. This issue has unfortunately taken me away from my master's degree program because of the severity. Last July, I suffered from a spontaneous right leg swelling that started from my right knee down into my foot and it took me having to go on a water pill just to bring down the swelling. Also prior to all the fall's I had my implant set at 1.3-2 without any form's of discomfort now my urology specialist office can't even get it to 1 without me being in pain. I have never suffered from my ear's ringing until December of last year. As I had mentioned I just turned 35 this past February and I'm very concerned. I suffer from Raynauds disease (circulation disorder) as well in my leg's and feet that is now starting to affect my hand's more. My dr/surgeon say's it's a simple fix but if the neuro issue's are a result of the implant is this permanent??? If it is permanent, do I have to worry about it getting worse???

I have always been proactive in my health ever since my accident that killed my best friend's mom. The last thing I want is for my almost 15 year old daughter to loose her mom due to complications related from the interstem. Has anyone else experienced any of the symptoms I've discribed???

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I had an Medtronics Interstim devise implanted for bladder control in 2007. Within the year they had to switch leads in the back because leads weren't working. In 2008 due to pain they removed the unit and replaced it with a new one on the other side of my back. They said the unit leaked internally and discharged around my spine. The pain remained in the same place and the new unit didn't improve the bladder control. In 2015 I had the unit and the leads removed so that I could get an MRI to find the problem. The MRI showed collapsed disc for which I had back surgery. The simple back surgery that was supposed to be over within 1-2 hours turned into 6 hours because the nerve were bound up in scar tissue at the lead placement sites. Pain is now gone after 8 years due to this device.

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I had two put I my back one was for three years and had to have that one replace and now I have one which was suppose to last 9 years and it will not charge up and right now it feel like it burning inside it very painful

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I am 48 years old and had the Medtronic Interstim permanently implanted a year ago. I had lower back pain, restless leg, neuropathy, constant sensations in private area and other symptoms much like mentioned on this site. 8 weeks ago, a lead moved and was SHOCKING ME SO SEVERLY THAT I FELT ELECTROCUTED! I was hospitalized and had no feeling from the waist down. I could not feel my legs( thought I would be permanently paralyzed) so could not walk and I could not make water (Catheterized). My teeth were chattering so severely that I have chipped teeth and two teeth moved out of natural gum position. I truly was CLOSE TO DEATH BY ELECTROCUTION. I HAD RESIDED WITH THE THOUGHT THAT I WOULD NEVER SEE MY SON AGAIN! By the time my husband was able to get the remote, I could not talk or process any information to tell him how to turn off the device. Panicking, he was flipping through the book and finally found the procedure to turn off the device. I was instantly relieved of the shock, but could not feel anything from my waist down. I begged my doctor to take out the device for I felt it was still shocking me lightly after being turned off, and he performed surgery the next day during lunch( the only time the operating room was available) to remove the device. He said that the lead was displaced and used fluoroscopic photographs that showed abnormal distal positioning. He said the lead had tips that were bent backwards(suppose to be downward pointing) and were embedded in a nerve bundle. He also said that the electrode lead had a fair amount of redundant mobilization... MOBILZATION AS IN MOVING AROUND IN MY BODY. THIS DEVICE SHOULD HAVE A FAIL SAFE DEVICE TO SHUT OFF INSTANTLY WHEN MOVED! If a person were to be in an accident and were unconscious, they could be electrocuted to death, and no one would know! I have had cancer, cancer treatment, and given birth. This is worse than all three put together! THIS IS THE WORST EXPERIENCE OF MY LIFE. I have been confined to mostly my bed for 8 weeks now. I have had heaviness in my legs, cooling and heating sensations, problems still processing information, tingling sensations in my private area, problems emptying my bladder, and severe leg and back pain( I have gone days without any sleep( because of the overstimulation) and weeks with very little rest. I went back to my Internal Medicine doctor YESTERDAY who had all the reports sent from other hospitals and doctors. He said I was electrocuted internally that killed nerve cells...hence the no feeling below my waist at the time. The sensations I have now are new nerve cells growing and awakening. Since nerve cells grow slowly, it will take 9-12 months to get back to any sense of normalcy. I AM POSTING THIS SO NO ONE ELSE WILL EVER GO THROUGH WHAT I HAVE BEEN THROUGH. WHATEVER YOU DO, DO NOT GET MEDTRONIC INTERSTIM IMPLANTED. I am a school teacher and president of my own corporation, and MY LIFE HAS BEEN CHANGED FOREVER! Success for me now is making water and walking...

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I had the interstim trial, after a painful nicking nerve????, it was successful. Got the implant put in. Few months in had to have another surgery to re position the leads and few months after removed it due to not working. Went iin and had to reprogram it and everything. I was getting more panic attacks and felt it affected my heart that it kinda "skipped". I have sciatic problems but feel my lower back pain has increased and having pain at the site, sunk in (3 surgeries in the same spot) and so painful in my right hip shooting down my leg. I feel that it has made my situation with my bladder and back soooo much worse and left with a ugly scar! My advise is DON'T get it!!!!!!!!!!!!

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I had great success with phase 1. And with phase 2 I had to have the wire replaced after being sexually assaulted which my dr. told me caused the lead wire to break and dislodge...then I had surgery and was fine after recovery until randomly id get severe pain from my incision site all the way around my right hip to the point my hip gives out dropping me to my knees. I made an appointment with my dr and he set up surgery to revise the pocket finding out the battery was rotating in a circle. So my dr placed the battery an inch deeper and said this should resolve the problem, it did for awhile and now the pain is back even worse I can hardly walk and I have 2 toddlers that I cant lift on my own in fear my hip will give out and I'll drop them.
Has this happened to anyone else, if so any advice?

PLEASE HELP!

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I think it is a shame that a person has to suffer with the pain in your muscles and wetting on yourself for 7 years and have to through this and have no one to help you. the bladder stimulator side effects are horrible and I was never told the side effects if it don't work right I RECENTLY HAD IT REMOVED BECAUSE OF A MALFUNCTION AND I would recommend anyone that needs this done to not go there Medtronic is for themselves and don't listen to some of these doctors probably getting kickbacks

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I did the Medtronic trial and had great success. The feeling was a tapping effect and it helped tremendously! I was sold. My first implant was 5 years ago and it has never worked right. I have pain in the vaginal area whereas during the trial period I had the tapping feeling. I have been to my Dr. Office many times to have it reprogrammed and have never been able to achieve the success I had for the trial period. This last year I asked my Dr if she could try replacing the lead but she wasn't interested and suggested I try Botox injections which I will not try because patients then need to self-cath. I have called Medtronics about my issue and get no answers.

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I am looking for a product liability attorney to help me with a
RestoreSensor Model 37714 Medtronic Neurostimulation System that is
surgically implanted in my lower back 4/4/2012.
I have had 3 painful surgies to correct extreme pain caused by the
electrodes after the Medtronic Neurostimulation System LEADS broke.
This seems to be a regular problem that Medtronic's
has always known about but I was never told of these problems.
I have had a lower back fusion in 2007 and back pain since than, so the
Medtronic Neurostimulation System seemed to be an excellent choice.
The Medtronic Neurostimulation System did work great as to relive me of my
back pain and mostly to take less pain medicines such as Percocet 10/325.
This is now a major setback I feel that now has False promises, in that
Medtronic knows of these electrodes and leads causing major problems.
I BELIEVE my problem is not just the broken leads that a recent X-Ray
showed, but the main stimulation system itself failed and now sends an out
of control shock and pain impulse that I was not told could happen.
June 27th 2013 the Medtronic Neurostimulation System broke inside me to
where it shocked me painfully and uncontrollable until I struggled to reach
my remote control to turn it off. If I was not home at this time to reach
the remote control this would have been a torturous pain that I could not
have stopped until the device was turned off.
The Medtronic Neurostimulation System will now need to be surgically removed
permanently as I never want to be in this painful situation again.
I am disabled on Medicare at age 49 since 2008 from Colon Cancer and back
problems and cannot afford to have this painful operation.
I now feel that I have been taken advantage of for there own experiment as
to how these leads break.I had my Doctor remove the Medtronic implant Tuesday the Oct 15th 2013.
I believe these leads where moving around in me freely as much
as 6 inches or more from where they were originally placed, X rays would
show the severe pain this movement was causing me. The pain I am in at this
time has me wondering how well the surgery went. Did the doctor cut me too
much to take out the broken wires he was removing? I should mention here
that Dr. T is not a surgeon. However, thats the least of my concerns
right now.As I mentioned, I have had and am still having major pain and suffering from
this implant and realize that this company was just using me. I saw a
segment on Good Morning America, Monday the 14th about how it can or can
not help you. Also I feel Medtronic representatives had no concern for me
and never offered any help or solutions which was very upsetting to me.
When I was in the waiting room the 15th, the Medtronic Rep walked into the
Doctors office and I had to address him. He would have just passed me by if
I hadn't addressed him. And he KNOWS me! After that initial greeting I
never saw the rep again. I presume he was there only to collect the
mechanism, which I felt I was entitled to keep in my possession.( I asked
for the mechanism and was told that I could not have it.) When I had the
operation, did I BUY the mechanism or did I just RENT it? Considering the
mechanism cost $20,000, I think I have a right to know! The fact that the
Medtronic people showed no concern and made me feel like a worthless Guinea
Pig leaves me with a feeling of hopelessness and helplessness as to my
future and quality of life. I still do not have the funds or know how to pay for this operation. Doctor
T and I agreed that there would be no cost to me as I told him I could
not pay anything at anytime for this. He did cancel the initial bill for
$3,500. I would like to pursue this matter because I feel very strongly
that, in addition to helping me, other people should know what this company
is doing. No one else should ever have to go through the pain and suffering
that I have. The lack of concern and the riskiness of the machinery alone,
is enough, but the insufferable pain endured is unforgivable.
I am pleading with you to help in this cause.

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Had the interstim put in on Dec 10 2014 for overactive bladder issues.. apparently I was not informed how to correctly use the stimulator, by the time I went back for my 3 week check up I was in pain, numbness in my right leg, toes were cramping up, it was then they told me I had the stimulator turned up to high... i had it up as high as 3.9 to 4.5...nurse told me should b set .5 to 1.9 never any higher oops!!!! Mind you I had talked to medtronic rep day after surgery she never
discussed with me what strenghts I should stay with in....well after 2 weeks I went back to work, my job is physical, bending lifing, in & out of vehicle 60 or more times a day. I began to go downhill with my recovery, when I move or rub area certain way I feel this shocking screaming pain, brings tears to my eyes in the incision area, then I get really sore in the area where the leads were implanted, I hurt in the center of my spine and my right hip after I am up on my legs for several hrs...so I filed FMLA for more time off hoping more rest will alevate & heal pain, but im beginning to wonder after reading other posts...let me be clear it certainly has helped w my urgency problem, but has caused other the issues I am now dealing with.. if anyone out there has advice please respond...

Posted by

on
Had the interstim put in on Dec 10 2014 for overactive bladder issues.. apparently I was not informed how to correctly use the stimulator, by the time I went back for my 3 week check up I was in pain, numbness in my right leg, toes were cramping up, it was then they told me I had the stimulator turned up to high... i had it up as high as 3.9 to 4.5...nurse told me should b set .5 to 1.9 never any higher oops!!!! Mind you I had talked to medtronic rep day after surgery she never
discussed with me what strenghts I should stay with in....well after 2 weeks I went back to work, my job is physical, bending lifing, in & out of vehicle 60 or more times a day. I began to go downhill with my recovery, when I move or rub area certain way I feel this shocking screaming pain, brings tears to my eyes in the incision area, then I get really sore in the area where the leads were implanted, I hurt in the center of my spine and my right hip after I am up on my legs for several hrs...so I filed FMLA for more time off hoping more rest will alevate & heal pain, but im beginning to wonder after reading other posts...let me be clear it certainly has helped w my urgency problem, but has caused other the issues I am now dealing with.. if anyone out there has advice please respond...

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i also gad the bladder device put in, which did not work. in total desperation i let them convince me to try another on the other side. after a very short time i decided to turn them both off. all i got was horrible pain from them zapping me. my big toe would not stop moving. i found i nice doctor to remove them for me because of the pain and i wanted to have a mri for baack issues. well...........now i have wired inplanted in my bladder due to the wires fraying during surgery. i would love to start a lawsuit

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I had interstem put in April 2012 and now I'm going Dec 9 2014 to remove it bc pain I get in my back and going down my legs when it one and pain from where it was put in but got turn of so pain in back and legs better but pain where it locate is not

Posted by

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Reading everyone's comments is really troublesome. I am on my second device and I'm having a lot of pain where the device is implanted to the point of having a hard time sitting and sleeping. This device has not worked. I still have to cath 2-3 times a day. I still cannot completely empty my bladder and if I don't cath, I get UTI's. I thought this device would stimulate my bladder and I wouldn't have to cath so much. That's what I was told. Found very little help from urologist about this thing. it's like put it in there and forget about you. I'm thinking I need this out ASAP. Please put me on the list for a class action suit. Now, I'm afraid what will happen if it's tKen out. Thanks for listening.

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I just have to tell y'all about my what I just did. I called my Neurologist and Urologist about the terrible pain, heaviness and numbness in my legs.I have also been diagnosed with RESTLESS LEG SYNDROME and NEUROPATHY. I turned off my device and have gotten 50 o/c RELIEF. I can urinate alright but don't empty my bladder, but I would rather self Cath then go through what I have been going through. Maybe just maybe we should document all these horrors stories and submit them to the FDA. They need to know of these horror stories. For some of us this device has been a nightmare.Maybe others are doing alright with it but for some of us...it is a nightmare. So maybe we should find out how to GET all this documentation to the FDA. I can not emphasize how much better I feel. Yes I still have RLS but I am not a diabetic which is putting me in a 15o/o who have it without being a diabetic. Maybe my nerves will heal some since they are not being irritated by the device on a minute by minute basis.

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I have been having problems too. I haven't been able to sleep in my bed for almost 2 years. I do have degenerative disc disease in cervical and lumbar. I was not able to urinate and never emptied bladder. The interstem was put in 2/21/2012 and seemed successful for awhile. However I have had, pain at the sight and have a huge circle that can be felt in my butt. I have not been as to sleep in my bed due to the pain from the interstem and down my leg. I now have neuropathy in my legs which I did not have before the devise was implanted. I turned it off and in trying to do it, the thing blasted me on the inside of my leg and somewhere in my groin. I have read your tales of horror and am positive this mess needs to come out. I would much rather do self Cath. The pain in my butt where the interstem is placed hurts all the time. I also noticed it feel like it has a dent in it. So we are ALL SUFFERING FROM THIS DEVICE but we are not able to get it taken out unless WE PAY FOR IT and Medtronic says there is nothing wrong with the devise...right?? I am in pain from this devise...how can we all get together too make them take it out at their cost and pay for our Cath products? My last payment for my interstem is next month. I made an appt. With my Urologist to get this piece of cheap taken out. I think it is a lot of my problem and I can't even sleep in my bed because of the pain it causes and is now causing while sleeping in a chair. THANK YOU SO MUCH FOR YOUR COMMENTS..I THOUGHT I WAS THE ONLY ONE.How can we help each other??? Have a, BLESSED Christmas and New Year..

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My interstim was implanted about 9 years ago. Do to Military Suicide of son and subsequent divorce I no longer have health insurance. I have had an infection for two months at the site, its bad. Trying to fight it myself because medtronics said they are no longer responsible once it is implanted. Because of several deaths in my familiy I am the last daughter my mom has. I have had a blood infection because of this and feel if something is not done I could die of this infection. If in fact I do Mom has orders to sue Medtronics. Do not want it to come to that. Please if there is anyway to get medtronics to do something about this that you know of let me know.

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I am about to have my 1st one replaced due to it been broken. The doctor states that she don't how or why the wires broke away from the box.. I am scared because this will be the 3x me attempting this.. 1st I caught a infection; 2nd it took me getting cut on the other end because they couldn't get it in one side and the pain was tearful... I am about to have this performed by the same doctor at Alabama Top Hospital... Anyone ever had there done in Alabama and how was your experience

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I had my interstim put in 7 days ago, it has releived 90% of my problems....my bladder was working at about 10% prior. At the 5 day mark i went to sit in the car and i felt fire burn at the interstem site thru to my rectum. I now can only stand if i want to deal somewhat with the pain. .Thought i may have overdone it so i have laid down for 2 days. NO RELIEF!!! Called the doc she wants me at the hospital tommorrow morning....WHATS GOING ON, IM SCARED!!!!! Any info is appreciated!!!!!!!!!!
Or email mr at dmartinez1170@gmail.com
Thanks for any help!

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I had my first Interstim by Medtronic put in in 2005 because of continuously running to the restroom. It never worked and shocked me at a moment's notice. I had several visits with the doctor, and they decided that I had turned the very large Interstim up to high and the battery needed to be changed.

So, they put in a smaller device, but the lead wires are right at the bottom of my spine. I hurt all of the time, and already had degenerative disc disease, so this really hurt my pain. I thought possibly a new battery would aleviate my bladder problem. No one believes someone goes to the restroom 70 times a day...and night. So instead of changing the battery, they put in an entirely new device as mentioned above. Well it didn't work at all. I have this device in me that doesn't work, and the doctor and the Medtronic Representative are telling me it is because the wires need changing.

So I go in to have the wires changed and they put in another Medtronic Interstim....and then tell me they couldn't change the wires, they had to put an entirely new device, the same model number and everything. Well here I am still going to restroom 50-70 times a day and night, so I went to see two more urologist. The first one referred me to another one in his office that put Interstims in and takes them out. The third urologist tells me I need to go back to the urologist who put it in and have it taken out, he is having nothing to do with it.

So I go to a fourth urologist, they do x-rays and cannot find the lead wires, and I am in horrific pain all the time running to the restroom every few minutes. Since 2005, I have been a prisoner in my own home. Even if the Interstim is taken out, I am still going to have the same problem. The PA in the office turned it completely off because she could not figure out why it was shocking me.

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I HAD MY FIRST INTERSTIM PUT IN 2011 AND THE SECOUND 2012.I HAVE STILL HAD NO RELIEFE WITH BLADDER PROBLEM.I HAVE PAINS SHOCK SWELLIN DAMN THE SWELLING,AND SO MUCH PAIN I SEE THE DR AGAIN THURSDAY I JUST WANT

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So I am 34 and had mine implanted a few years ago. I have many of the same problems as everyone on this site and too am looking for an attorney or somewhere to go to help with all of the cost and now the debt this has caused me. Has anyone found anything?

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I had an interstim unit implanted nearly a year ago. The test went OK, so they put the permanent one in. I had trouble getting it to work, I was constantly having to turn it up or change the program. Then I started getting infections. I had a "bubble" appear at the surgical site and it burst open and this bloody, pus filled ooze came out. That was my first ER trip. So I had an abscess and first round of antibiotics. It clears up and about three weeks later it abscessed again, more antibiotics. I did that four times. On the FIFTH time it burst open and I felt this hard plastic "thing" under the skin. I was so sick with infection that I had to call the EMT'S again to take me to the ER.

At the hospital I was told the device was "coming out", that was the hard plastic thing I was feeling. They transferred me to the hospital where it was put in and my urologist removed it the next day.

Following the removal of the estim, I spent a week in the hospital and SIX WEEKS in a nursing home to keep the sight packed so it could heal properly. The wound I was left with was at least 9 inches deep and it took about 9 weeks to heal completely. This has been a horrible experience and my doctor and his staff had lied to me over and over again. I was told that infections were "rare". Something that is rare is not plastered all over the Internet. I think this kind of crap is criminal. I was so sick I thought I was dying. The infection was so persistent, I was sick for months with it. And I kept telling my doctor and the ER doctors I wanted it removed. Not until it tried to come out on its own would my doctor even talk about removing it.

I cannot believe there is no class action lawsuit over this. It certainly seems like there should be. I'm now looking for another urologist because I no longer trust the one I had. It's a bad deal all the way around.

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I have had it put in three times it's malfunctioned all three times I've had infections in my battery pockets that they insert the battery in ur skin fatty area and my body keeps rejecting it pushing wires an battery to just under my skin all my areas itch constantly where I had all three surgerys I'm looking to have lawsuit done on this

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I had my interstim put in October 2012. A year and a half later its now malfunctioning. Jolts me whenever it damn well pleases sending me into screaming pain.y doctors office has been giving me the run around when it comes to this. I just went for my appointment today where the interstim specialist was supposed to be there to check it. Which I had to fight and threaten them with a lawyer to get the appointment. Well what do you kno the interstim specialist never showed and I am still left with a malfunctioning device inside me and no one to help me with it. If theres a lawsuit going please let me know.

Posted by

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I had my interstim put in feb of this year and it has been awful. I hate it my leg is numb and swells and I have hip pain all the time and the stimulation is not where it is suppose to be at now. I would not advise anyone to get this I am going tomorrow to the doctor to talk to him and try and get it removed!

Posted by

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I had the device implanted in November of 2013 and it has been one of the worst experiences of my life. The pain and discomfort is unbearable. Im so depressed and angry because I feel as if I have been mislead. Even with the device turned off I feel as if some is stabbing me in both sides of my back with a hot ten inch knife. I am having my device removed on 7/15/2015. I have seriously been thinking about contacting a Lawyer about this issue, and after reading all of these other posts that thought is more prominent.

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Oh my god!!!! What have I done!!! I got this interstim put in last week Thursday. I had the check up with the doc on Wednesday.. All seemed well! I was no longer racing to the bathroom and there really was minimal pain... Then I bent over.... I felt something funny and then later I couldn't bend or straighten my leg without excusiating pain. Since then I have had to turn up the stim device. ( still in phase 1) along with turning it up I get a horrible pinching pain when walking. I can tell, something just isn't right!

Posted by

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I had the interstim put in 2009 I have had 3 surgery had to get new device in june of 2013 still not working right call 3 attorney no will take my case . help !!!!!!!!

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i too am having serious pain in my hip,back,leg,groin,this my second and on the first one the 5 years of battery life was used in a few short months.i want to just die from the day to day pain.

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Hi all. Im from the uk and had mine implanted in July 2010. It has never worked so turned it off a few months back. Since implantation I have suffered with blood clots, pain, lightheadedness, pressure headaches, low blood pressure, metallic tastes to my food, hot flashes and burning sensations. I am currently scheduled to have a brain scan but came on here to see if it could be linked to my implant. seems like it could be. Does anyone have any information as to what the next stage would be?

Thank you

Posted by

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Hi all. Im from the uk and had mine implanted in July 2010. It has never worked so turned it off a few months back. Since implantation I have suffered with blood clots, pain, lightheadedness, pressure headaches, low blood pressure, metallic tastes to my food, hot flashes and burning sensations. I am currently scheduled to have a brain scan but came on here to see if it could be linked to my implant. seems like it could be. Does anyone have any information as to what the next stage would be?

Thank you

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I have OAB & IC. I've been taking medication for about 20 years. I found a new doctor a few years ago & he pushed the Interstim Therapy on me. After a few years of thinking about it, I decided to try it after I had my second child. I had my Interstim device implanted March 12, 2014. The device did not settle correctly and is now poking through my skin causing a lot of pain. It is very painful to even sit down. The device hasn't even helped my condition like my Dr & the Medtronic rep said it would. Last week the rep came to my post op to make adjustments. Other than the increased vibration in my crotch & big toe, nothing has changed. I turned the device off yesterday & I asked my doctor to please remove it. My Dr tried talking me into repositioning surgery, but I insisted on its removal. The pain is not worth it, esp if the device doesn't work.
The removal surgery is scheduled for April 30,2014.

I agree with the class action lawsuit. We should do it .

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In 2002 I was diagnosed with Interstitial Cystitis. I agreed to try Interstim device for control of pain and possibly control incontinence. This was the first time my doctor had attempted such a procedure. They implanted the devise in my right hip forming a pocket for the battery pack. The first couple of months were not much of an issue. Then around the third month the device started to malfunction. It would increase in strength on its own or quit all together. When I mentioned this to my doctor he was inclined to believe I had done it myself even though I always left the hand held devise used to change frequency at home. The pain I was experiencing from the incision point was terrible but my doctor just kept saying it would take time to heal and to live with it. After about two years of putting up with frequent malfunction and pain from having the devise put in I asked my doctor to remove it and the leads. Medtronic came to the removal and stated the devise was working perfectly. To this day my spine sends signals to my lower back and will spasm as if stimulated. The incision site has never gotten better, the pain from sitting or having anything rub against the site is very painful. I was never told if the leads were broken but I know it did not do what they said it would.

Maybe evyone on this site should form a class action suit against Medtronic. If anyone wants my advise do not allow your doctor to implant a Medtronic devise.

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Mother passed after receiving the interstim

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Hello Everyone,

I have briefly read through a few of these. I have conducted so much research on this thing because my mother passed away right after surgery. She was last seen approx. 1:30 in the afternoon then found dead the following morning.

I knew there would be a day people would have questions. I have done some extensive research.

I feel horrible because I promised my mother I would not let anything happen to her. She was so worried. I called her doctor in which the nurse called back and claim it to be a very simple procedure and that I was not needed. I told my mom this and it was as if she won the lotto. I have kept everything and continue to research. If anyone needs anything or has questions I will help the best I can. I am no expert but till this day. Medtronics has been known to pay kickbacks. I too think there should be a lawsuit and to get this device off the market completely. I have heard more negative things about this than good plus my mother is dead. I have not felt the same since nut to help or so a class action would be an inspire that I so much need. It still feels like yesterday. Not a day goes by that I don't think about her. My e-mail is N2AngelCare@yahoo.com and my name is Tonya.

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I need some insight. I had my interstem implanted in 2001(not sure of exact date). Ive been looking for anyone that has had any issues with theirs. Mine hasn't worked in years. Although i knew i was supposed to have the battery changed every few years, my doctor that put it in retired. Ive hay pain in the implanted site.Ive had numerous medical problems that came up with no explanation. I'm wondering since it's never been replaced is it possible the battery could have coroded and is leaking in my body? I seem to have some type of infection that will not go away. Ive heard the skin tells us what's going on inside. I'm continualy having skin infections. I'll do good on strong antibiotics but as soon as i stop, the infection comes back strong. It's like it's coming from somewhere deep in my body. Could this be possible?

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I had a "test" interstim implant about 6 years ago for bladder incontinence. I had pain and terrible discomfort the entire brief time, about 10 days, until I had it removed.Thankfully, I had insurance that covered the entire procedure. Of course, this was the entire reason why I was such a prime candidate. Foolishly, I was so desperate to find a solution to my problem that I followed the doctors recommendation like a lamb to slaughter. When we first consulted I was told I had three choices; medication, biofeedback or interstim device. I told him Biofeedback was my first choice. He set me up for a "test" that I didn't even realize was for the interstim implant. I was being prepped for the surgery when I was asked by the interstim rep how long and how many different solutions I had tried. I told him honestly "none, really'. I had the device put in, suffered excruciating paining my lower back and legs from the electric shocks, no relief and had device removed within three weeks. As an aside, I then requested to be set up for biofeedback. I discovered that my insurance would not cover and I could afford out of pocket so I did nothing more about that. I have always felt pain and discomfort at the insertion site. I am now being treated by a chiropractor for back, hip, and knee nerve pain that emanates from the sore spot at the insertion site. After reading these other posts, I am grateful that my trauma isn't worse!

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Wow, I can't believe this, I am on my 3rd simulator and just yesterday contacted an attorney, this last implant surgery was $55,000 and we are responsible for a large percent out of pocket, after 3x's of losing money, I've had it. Has anyone else sued yet and what was the out come, I hate suing but feel I have no choice, and I do not want to sue my Dr. he was being led by Medtronic's, I feel he did nothing wrong, the wrong is in Medtronic's hands.

Thank you,
Cathy

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Wow, I can't believe this, I am on my 3rd simulator and just yesterday contacted an attorney, this last implant surgery was $55,000 and we are responsible for a large percent out of pocket, after 3x's of losing money, I've had it. Has anyone else sued yet and what was the out come, I hate suing but feel I have no choice, and I do not want to sue my Dr. he was being led by Medtronic's, I feel he did nothing wrong, the wrong is in Medtronic's hands.
Thank you,
Cathy

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Hey we all need to get together and get a class action lawsuit against Medtronic never in a million years that I would have thought that something like a little device could take my lively hood my device has been out since 2012 it was put in 2009 had to suffer for three years before taken out cause I had to wait to see if I would win my disability case ???????????? doctor would not take out cause of no more insurance what I went through and still going through is horrible I now all to well about the pain,burning in the hip,nerve damage and etc.i thought I was getting help for my bladder problems ended up what a hole lot worse with it in me and now also out of me ???????????? it's so sad what we all are going through I know now I am not alone ????????????????????

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I need advice, after having 2 interstim devices put in and removed, my devices were defective and wires frayed leaving 3 wired deeply implanted in my bladder that cannot be removed.

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I had a interstim put in due to incontinence. after about a year of no results, doctor discussed putting one in other side and again ajustig the old one. I agreed due to desperation with my bladder control problem. soon after the pain and numerous bladder infections, I turned them off. later I was hit with a serios back issue that needed surgery. not knowing if some of pain could be due to bladder devices, I decided to have them removed. I found a wonderful dr. that was willing to take my case. I had just had enough of the dr. that put it in. during my surgery my family was informed the wires had frayed and implanted in my bladder. dr. said it would be too much digging and pain for me after to get the remaining 3 wires. now with wires and can never have an mri, which I need after 2 surgeries on my back. I continue to have bladder infections also. im not sure if I have case here. any advice appreciated

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I had the interstim "permanently" installed in late Sept 2013, after what appeared to be a successful 10-day trial of the test Interstim. The urologist recommended the device to me to treat urinary and occasional bowel incontinence.

Unfortunately, I have been having problems with the device which seem to be getting worse. At first, I noticed that I was feeling the stimulation in odd places (on the outside of the crotch area, not the lower inner labia as in the test, or in my rectum) and that I was continuing to have bladder accidents.

The urologist turned the device up to the point that it is mildly painful and told me to "try to tolerate it." After that, I seemed to not urinate much for several weeks and also became extremely constipated (which laxatives failed to resolve).

It appears that I now may have an impacted bowel and my bladder problems are worse (possibly in part due to the increased constipation). Today, I have had at least 8 accidents, two of which went thru the Depends and flowed onto the chair and the floor. I am now feeling the stimulation mostly in the rectum.

I called the urologist's office and they don't seem to be interested in trying to adjust the device further or remove it for me, but now want to inject Botox into the bladder to treat what they believe is overactive bladder.

However, I have done the Interstim procedure (despite my own qualms) based on their advice, and don't feel that doing another extreme treatment without really figuring out what is causing the problem and trying safer alternatives is a good idea.

As for the Interstim, I am not sure if it would work if the urologist were willing to spend the time to trouble-shoot it more with me, or if a wire slipped out of position after the surgery somehow, or what, but I would most likely NOT have the Interstim procedure again.

It really seems that my bladder and bowel problems are now worse. Perhaps the higher level of stimulation was too much, and my worsened symptoms are the "backlash" from the device inhibiting normal functions too much.

MJ

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Im looking for Attorneys for my Inter-stim problems iv had when I had put in and having the same problem now that it has been removed

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I still have the bad back pain, I had an ultrasound on my bladder and kidneys and they are okay... So now my urologist things I have scar tissue from the leads... ugh I wish I never got it! I am so glad I got it removed!

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Has any legal action ever been taken against MEDTRONIC for their Interstim Implant? I have had 2 (two) of them.

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I recently had mine removed. I got the interstim implant in 2008 had nothing but problems with it. Constant leg jolts, severe nerve pain in my leg, hip pain, made my whole body hurt, horrible heachaches, severe lower spine pain to the touch and I have gone into convulsions several times which my doctor instructed my fiance to turn it off if I have them because I am unable to do it myself. It caused me nothing but grief. Three weeks ago it was removed and I feel so much better although my spine pain has not resided. they put me on a new medication for my bladder that seems to be helping but are giving it a year to see if it works and if the pains in my lower back reside if they dont go away i have to go to an orthopedic surgeon. Getting the interstim was the worst mistake I made!

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I had the test implant done and was ready for the main implant because of the positive results from test. I was ecstatic. Than on night before scheduled surgery Doc's office called and cancelled saying something wrong with insurance but they would fix it and call back to reschedule. After not hearing from docs office I called 1 week later to see what was going on. I was assured they were workingon it and than received call for implant date.
I arrived at the hospital an hour early(6a.m.) was checked in and than called back to a room. Right before the surgery Doc comes in and says cant do implant insurance wants another test. The forst one was in office but they put me under for a deeper test implant I guess. First few days were great. Urinary retention was down to almost nil and bowels had slowed to 2 to 3 times a day, again my miracle medtronic. The friday a week following my surgery I awoke to stiffness and pain in my tailbone. I have dealt with a lot of pain so I tried to just tough it out. By 8:30 that evening I could not get up off of the couch I was crying and had my son bring phone to call for help. My mother-in-law Helped me to the ER where they asked if I wanted a wheelchair I stated no because of the pain caused by the sitting or standing and I knew I would not be able to get out of the wheelchair. Finally got to a room and my mother-in-law helped me onto the bed. I laid there facedown unable to move from the excruciating pain. They did CT, labs, low grade fever of 100...etc... but found nothing and were going to release me. My wife told the doc that I was not able to get up and had laid there face down unable to move for four hours. She than stated that someone would have to carry me to the car because she couldn't and I was in no shape to even make an attempt. The doc than called urologist on call and they admitted me for observation. I was told no infection yet they put me on a regimen of vancomycin and gertamycin via IV. I began to feel better and was ready to go home after a 2 night stay. They sent me home with pain meds and a 30 day supply of Bactrim. I am still confused about all the antibiotics with no infection present(susceptable to infections) and a history of c-diff.
I have been home now for 2 days and the pain is back with a vengeance. I can sit maybe 30 minutes before the pain is to great, laying down comfortably is all but impossible, and going from laying/sitting to standing is intolerable. I called the docs office today and they said he is not in until tomorrow which is the day before my surgery and I really need to talk to someone about this before I make this decision for a permanent implant. The results are great as having to self catheterize 3 times a day and bowels moving plus 10 times a day. However, If I can barely walk in exchange maybe not so great. Forgot to mention while in hospital doctor asked me for the Medtronic reps name and number because he wished to talk to him. I would think they would have a number but oh well. So goes my life. Another miracle down the drain after 11 surgeries, multiple infection, multiple hospital stays, etc....
You know its bad when someone would rather cath 3 times a day than deal with problems caused by the device supposed to fix them. Need help. Need understanding. Need direction

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I'm as disappointed as everyone else. My insurance was smart enough to not pay for it, but I paid several thousand, out of pocket. The hospital wrote off a large amount. It didn't take long for my Interstim to stop working. Now I'm having terrible pains in my right hip and the area of the Interstim. I'm so sorry I ever had this, but you would do almost to get help with incontinence. Somebody should close this company down.

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Hello,I too had a interstim devise implanted to help me get rid of the urges to have to use the restroom every 30 mins but it completlety failed and mailfunctioned inside of me.I am a 33 year old male that has been fighting IC for almost 8 years now and to anybody whos reads this who is thinking about getting a Medtronic Interstim Device implanted I reapeat DO NOT GET A MEDTRONIC INTERSTIM DEVICE IF YOU HAVE IC ! It most likely will not work and just break inside of you.So now on top of dealing with the miserble IC 24/7 daily pain and agony symptoms I now also have to deal with testicles that ache and feel swollen .I am almost 100% certain the Interstim is responsible for the pain and numbness I am feeling now in the testies becasue the first day I had the Interstim surgery I told the Surgeon why are my testicles vibrating with that electirc pulse sensation put out by the interstim? The Surgeon looked at me very confused and right off the bat I was hating the devise. I had the interstim inside of me for over 2 years and I begged to get it taken out a year ago but the Dr's wouldent let me.I worked with the Medtronic Programers to try to get the sensation out of the testicles and to try to get the sensations sent somewhere else but that failed of course. Now sitting here 1 month after the removal of the interstim still feeling the unwellcomed sensations in the testies I am here to say F*CK YOU MEDTRONIC! I hope your stupid little company burns in hell and you guys stop pushing Doctors so hard to install your garbage product in poor victims lives.IC patients allready have to deal with enough Bull sh*t. T

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hey people, im very disappointed with your relates.

im from brazil and was searching for this kinds of treatments and pacemakers, but now im not that much excited with this device....

it seens a very unfunctional thing...

do you know the rate of unsuccessful improvment of it?!

thanks, answer me please...

gabrieldouran@hotmail.com

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I had an interstem made by Medtronics implanted two years ago and 3 weeks after it was implanted I had it removed. The stimulator felt like a live hot electrical wire inside me when it was on and it hurt me. We tried various settings to no avail. My body could not accept the stimulator and the problems REALLY began when it was removed. As a result of having it put into my sacril nerve and then removed, I have ongoing issues and my quality of life is and has been sooooooo negatively affected. I have been undergoing a continuation of bladder installations for my I.C. and accept that. However the ongoing physical therapy for the damage the stimulator caused is another matter. Where the lead was attached to my right pelvic bone affects my right leg and absolutely affects every single step I take. My right leg swells and an old injury came back with a vengance. Is there anyone out there that has had the same issues?

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I feel for you. I have had my pacemaker since May 30,2012. I was told recently while at my dr. office it just wasn't working for me. I also was told that my battery will go bad in 6-12 months and it will not be replaced. I asked if they would remove my pacemaker; they said NO I will never recommend a Medtronic pacemaker to anyone!!!!!!!!!!!!!!!!!

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I also had the Interstim...it failed...ended up with major infection inside my body from that thing...missed work also, major emotional issues with it...frustrated husband from the whole ordeal...never again...never!

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