Wyoming, MI: At 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.
The 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."
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 ????????????????????
Posted by denise ashburn
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.
Posted by denise ashburn
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
Posted by mj
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.
Posted by willie marable.jr
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
Posted by Sarah Parker
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!
Posted by S D
Has any legal action ever been taken against MEDTRONIC for their Interstim Implant? I have had 2 (two) of them.
Posted by Sarah Parker
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!
Posted by Christopher Lee
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
Posted by Sally
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.
Posted by Sean Johnson
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
Posted by Gabriel
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...
Posted by Candy
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?
Posted by Patsy Hoffman
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!!!!!!!!!!!!!!!!!
Posted by Kathi Perkins
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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