Medtronic Patients Report Problems with Occipital Nerve Stimulator

December 23, 2007, 6:45AM. By Heidi Turner

Rancho Mirage, CATanya 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.

Tanya 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.