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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.

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READER COMMENTS

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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