Sprint Fidelis Leads: Medtronic should be Honest

December 20, 2007, 7:30AM. By Heidi Turner

Montpelier, VAJane Adams has been dealing with Medtronic since 1999. Prior to having her defibrillator implanted, she trusted the medical device company. However, since a defibrillator with Sprint Fidelis leads was implanted, Adams says she has lost faith in them.

"My pacemaker was implanted in 1999. It worked very nicely and it turned my life around," Adams says. "But my heart was wearing out and I needed to have a defibrillator put in. After a discussion with my electrophysiologist I decided to have the defibrillator put in on the left side. I made that decision based on how long these devices are supposed to last and because the left side was a clear route to the heart. My pacemaker had been on the right-hand side, so I decided that the defibrillator should be on the left-hand side, which hadn't been used."

Adams' defibrillator was implanted on July 6, 2006. Three months ago, Adams went swimming when her defibrillator gave her an unnecessary shock. She says that it was painful but the shock only happened one time so rather than seeking medical attention right away, she spoke to a Medtronic representative at her check in.

"I don't know if people know this, but Medtronic's people do the checking on you," Adams says. "They do the hook-ups and the check-ins, so you deal with them a lot. When I mentioned the shock, they told me that the pool triggered it. But I swim in that pool all the time. It has never happened other than that one time. Now I'm worried because I don't know if I have a faulty lead."

Adams says she does not know what she is supposed to do now that her defibrillator has shocked her. "When I felt the zap, I thought maybe the leads can't hold the power from the defibrillator," Adams says. "Medtronic hasn't made it clear why the leads fray. Is it the movement and extra exercise or is it the power from the defibrillator? Am I supposed to just continue on with the leads in my chest and once 30 months has passed we'll know for sure if my leads are frayed?

"I'm scared of what the device is doing. I'm not comfortable with it. How do you know it is working? I feel so angry because I had a pacemaker in one side and now I've got a defibrillator in the other side and it might be messed up."

Adams says that Medtronic representatives have not been helpful in answering her questions. In fact, some have been downright rude. "I went to one meeting with a Medtronic representative and there was a woman there who appeared to be with Medtronic, too." Adams says. "I was talking about how worried I am and saying that if Medtronic knew about these problems, they shouldn't have put the leads in. Then I said that I was happy that at least my devices have kept me alive so far. She said to me, 'I'm glad you're finally grateful about something.' I just said to her, 'It's not in your chest. You have no idea. You're not the one who has to be worried about it working.'

"Prior to this incident I felt safe with Medtronic. I would never have said anything bad about them. But after this I feel very let down and uncertain. I feel like they knew about the problems a long time before it came out. I think they know more than they say. They should step up to the plate and be honest about what's going on. There has to be more to the story than just 'five people are dead.' I want to know the truth.

"No one has ever spoken to me about faulty leads. No one mentioned that it was a risk. It seems like they should have said something. How can they get by with not telling the truth?"