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Medtronic Patients Report Problems with Occipital Nerve Stimulator

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Rancho Mirage, CA: Tanya does not have the Medtronic Sprint Fidelis Leads implanted. In fact, she does not have any Medtronic defibrillation device implanted. What she did have, for three years, was a Medtronic Occipital Nerve Stimulator, a device that required the use of four leads. However, after numerous device and lead breakdowns, Tanya had the whole thing removed.

She now says she would never recommend a Medtronic device to anyone. Her experiences are very similar to what people with the Sprint Fidelis Leads have gone through.

Medtronic PatientTanya had the device implanted in 2003 to help deal with severe nerve pain. Basically, a muscle was smothering one of her nerves, which was causing migraine-like pain. "I was getting 16 injections every couple of months, but those stopped working," Tanya says. "So my doctor recommended a Medtronic Occipital Nerve Stimulator to stimulate the muscle to reduce pressure on the nerve."

The nerve stimulator is designed with two leads that run to her right and left occipital nerves and down to her shoulder blade, where a metal plate is implanted. The metal plate has connecting wires that then run from her shoulder to a battery pack, which is implanted under her arm.

Within weeks, Tanya experienced the first problem with her nerve stimulator: one of her leads broke and she had to go back in for surgery. "It is incredibly painful surgery," Tanya says. "You have to be awake for it and I could feel them pushing the lead into my head. I had that done a few times."

Tanya had five different surgeries to fix broken leads and battery problems. "It went on like that for three years," Tanya says. "It never worked properly. I was going in to doctors constantly because it wasn't working. When the leads broke, it hurt. One just sizzled and died—that one I really felt. In another case, the lead moved and quit working."

Throughout those three years, Tanya dealt not only with the pain when her leads and nerve stimulator quit working, but also with the nerve pain that the stimulator was meant to fix. She was still experiencing migraine-like pain every few weeks. To top it off, she now has pain from the surgeries she went through.

"I have constant pain in my neck where they performed surgery," Tanya says. "I also have pain where the battery was. I have a lot of pain and scar tissue on my head from all the surgeries. It was the worst experience of my life."

"I think Medtronic should be liable. They shouldn't put things into people without letting them know there is an issue with these products. Medtronic was there at every surgery and there to program the devices afterwards. They knew all about the problems I was having but never gave any explanation or told me about the risks of my leads failing. People should be aware that Medtronic's products are defective. I would never suggest their products to anyone."

Although Tanya's concerns are not about Medtronic's Sprint Fidelis Leads, Medtronic's actions in Tanya's case are similar to the company's reaction to other customers who have problems with their devices. Once again, a customer has not been told about the risks and has suffered severe pain and repeated surgeries because her Medtronic device did not work the way it was supposed to.

"It was really terrible," Tanya says.

Medtronic Legal Help

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READER COMMENTS

Posted by
Carol Weiss
on
I had at least six surgeries related to my ONS. The first one worked great, but two weeks later I got an infection at the battery site that traveled all the way up to the occipital . Every since then, the lead placement just wasn't the same, and I had to take pain medics with the stimulator. I also had it replaced two more times plus two more battery replacements. After a while my right SCM muscle started getting really hard and painful. It started behind my right ear where the leads were and went down the front of my neck. The doctor told me it was nothing. This was after the third stimulator was put in. At this time my cortisol level also went down to 2. And I started having problems with my pituitary system. My muscles on the back right side of my neck were also enlarged. Though the doctor didn't seemed concerned. My aldosterone also went low and I was on medication to keep my blood pressure from dropping too low. I needed to get an MRI of my pituitary. My Dr finally took it out and charted I wanted it out for no reason and it was working fine. I guess he forgot to mention the pain, and everything else. After the operation, I started having even more neck pain than before.

Posted by
Scott McKay
on
RestoreSensor Model 37714 Medtronic Neurostimulation System that is
surgically implanted in my lower back 1/13/2012.
I have had 3 painful surgeries 6/2012 - replace peripheral nerve leads 11/2012replace peripheral nerve leads -10/1013 remove device - 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 am extremely disappointed with Medtronic sales
representatives as they are concerned more about the device that what is actually going on with me.


This is an update as pre request:

I had my Doctor Dr. T remove the Medtronic implant 10/15/2013 Tuesday the 15th. 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.
New WOW update
X-ray on 1/6/2015 shows doctor FORGOT to remove 6 inch lead that is still inside me now torturously starting to protrude from my skin.

Posted by
Kim
on
My daughter had one of Medtronic insulin pumps several years ago. It almost killed her! The pump kept malfunctioning and giving her too much insulin. I had to put a baby monitor in my 16 yr olds bedroom so i could hear if she went into a seizure. The first time, i called the company and they didnt know how to turn off the pump or disconnect it!!!! I didnt have time to read through the book while my daughter was in a seizure and dying in front of my eyes. The final straw was when the insulin for a whole day settled in the injection site while in her stomach. She didnt realize what was happening, it was midterm week. I got the call from the school she was in a seizure. I explained what to do, i was told of huge goose egg at the insulin site. I told them not to mess with it. I was on my way. I never made it. 2 blocks from the highschool, i was hit head-on but an old lady who forgot the bridge was out and came into my lane. Yes, i was seriously injured, but i made an officer go to the highschool to left them know. The nurse had gotten my daughter's sugar up and brought her to the hospital to be checked but also i wouldnt let them knock me out to turn my foot back around the right way on my leg until i saw my daughter was ok. Yes, as soon as i saw her the knocked me out. My foot was black, they didn't know if my foot was goona be saved. But my daughter refused pumps after that until this year. Shes now 29. That bulge is still there to this day.

Posted by
carman kanaeholo
on
I had Medtronic bilateral nerve stimulator inserted in 2005, it worked until the lead broke and came out of the back of my head on the right side, causing not only surgery for removal, but also airborne infection. Which they then gave me Rifampin and Vancomycin by PICC line. The doctor's assured me that I would be okay and if it relieved my nerve pain, that I could have a new one put in, however, this time the lead broke and stuck out of my back, so once again the same meds, PICC, and surgical removal. However, after all this was said and done, I now have a 90% hearing loss in both ears. All of this was due to the Medtronic device, I still live in pain, but would never again use them or advise anyone to use them

Posted by
85498644
on
I have having trouble with my stimulator ever since the first time I charged it. When I charge it it gets hot and hurts me. So I have to charge it in short increments. When I lay down on my back, the stimulator getting pressure from my body weight causes my right thigh to burn like it's really on fire, not even turned on. When I get up that area stays very sensitive on or off. I told them I didn't want it in my but to begin with. I feel I was pushed into the decision to get it. It does very little to help me.

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