Medtronic: "Proceed with Extreme Caution"

December 30, 2007, 7:15AM. By Heidi Turner

Bloomington, MNWhen Sarah was diagnosed with occipital neuralgia after a car accident, she was told that a Medtronic device would help take her pain away. However, Sarah did not know that the leads in her device would break, causing her to be shocked constantly, and she also did not know that she would have continuous problems with the battery in her device.

Sarah (not her real name) was first implanted with her Medtronic pacemaker in 2001. She was told by her doctor that she was taking part in Medtronic's clinical trials of the device, something that Sarah says no one at Medtronic ever disputed. She was also told that the battery life of her pacemaker was two to four years.

"Within four months, the battery died," Sarah says. "I was eventually told that I would have to go in every three to four months for the rest of my life to have the battery replaced. Isn't that ridiculous? And I kept getting shocked because the leads they implanted in me kept breaking. I had 18 surgeries in all, for the battery and the leads. I had four or five different leads and I don't even know how many different batteries. I even wound up with staph infections because of the surgeries. They put me on antibiotics for six weeks.

"The worst part about it is that my device was not approved for occipital neuralgia. The Medtronic reps knew what it was being used for in my case and they knew that it was not approved for that use. They knew that I believed I was part of a trial, but did not ever tell me the truth. I found out later that there was no clinical trial going on at that time."

Sarah had the Sprint Pisces Quad leads with the mesh implanted. Many patients have complained that their leads have fractured, even if they are not the recalled Sprint Fidelis Leads. "You are totally paralyzed when it happens," Sarah says. "You drop to the floor. I had too many shocks to count, but there were at least thirty or forty. It can happen at any time. Once I was next to a stereo system and I suffered a shock. Another time I was talking on a cell phone when I walked past another cell phone and I fell to the floor because of the shock."

By 2004, Sarah had enough of her Medtronic problems and phoned the company to take it out. Unfortunately, it took until 2007 for Medtronic to finally take out her pacemaker. "The device was even turned off for a while and I still got shocks from it," Sarah says. "For three years, I waited for them to get the pacemaker out of me and I was still getting shocked repeatedly. They finally took it out on February 16, 2007. That whole time, their reps kept calling me and saying 'We're still looking for a doctor who can take the device out.'

"Now, my husband has Medtronic products in him and they are going wrong, too. He first had them implanted in 2006 and they've been clogged twice since then. Medtronic is a bunch of bs.

"I'd just like to say in general: Be very, very careful when dealing with Medtronic. Proceed with extreme caution. You could wind up worse than when you started."