Wyoming, MIAt first, Lisa Kraft's story sounds like a classic Medtronic Sprint Fidelis failure. She had a Medtronic device implanted last fall; early this year, one of the leads failed, and a month later was found to have fractured. Now she's trying to decide what to do: Have the lead replaced? Leave the device in place and hope for the best? Get rid of it altogether?
The story diverges at that point, however. That's because she's not talking about a Medtronic implantable cardiac defibrillator (ICD) with defective Sprint Fidelis leads that are known to be subject to fracturing and have been recalled; she's talking about a Medtronic InterStim II implantable bladder pacemaker that's supposed to help control bladder problems such as chronic incontinence.
The InterStim II received fast-track supplemental approval from the federal Food and Drug Administration (FDA) in July 2006 as an upgrade to the earlier InterStim. Among the modifications noted in FDA's approval announcement was... thinner leads. Sound familiar?
Kraft (not her real name pending possible legal action) had an InterStim II implanted in November 2007. The device uses four thin leads that stimulate the sacral nerve to help with bladder control. The frequency of stimulation can be controlled via a range of different programmable patterns. Kraft, who works as a delivery driver for DHL Courier, says, "I've had a bad habit of wetting my pants," hence the InterStim II. She hoped that it would solve the problem.
In mid-January 2008, Kraft went in to her doctor to have the device checked. At that time, she says, she was told that the main lead was not working. "One month after my surgery and my main lead is already not working," she says. "They said it might be because it was in a fluid pocket, whatever the heck that is, and it's no big deal." A month later, she says, "I went in again and they said it was fractured and had to be removed and replaced.
"They said the lead was cracked, possibly from a pressure point. I'm a skinny lady and I drive and bend a lot, so they're thinking that between those two things, that's why it broke. Now they're saying that even if they do fix it, there's no guarantee that it'll work again. Meanwhile they billed my insurance company $45,000 for this thing and I didn't get two months' use out of it. I'm getting help from the state, which is helping me out through Medicaid because I was so far behind in my bills that they picked me up. I'm maxed out with my regular insurance. They only cover so much a year.
"This doctor's big on this thing; she implants them every week on Thursday, all day long. She's put in like a hundred of them. She said that another girl just had a problem with hers, and she's a school bus driver. But my god, bending and sitting is an everyday thing in any job—just bending and sitting!
"They knew all about my job and my size before they even went forward with this. Normally, you go in on Thursday and you can be back at work on Monday, but they kept me out of work for four weeks because of my job; she wanted to play it safe before I went back to work. I had to take four weeks of no pay at work, too. They don't give you unemployment if you're not available for work. I couldn't get workers' compensation either, since it wasn't a work-related issue.
"Before you have the system put in, a Medtronic rep explains everything to you, but once it's in it's just you and the doctors; the Medtronic rep disappears. I called Medtronic and said I wasn't happy about it. I asked who was going to pay for taking it out.
"They say it's not up to them, it's a medical problem and they'll bill it to my insurance. By the time this is all done, I could be out $100,000 or more. Nobody's really guided me about what to do. If it's a bad system, I just want it taken out. I'm a 48-year-old woman and I can't afford to be missing work.
"Now it's more or less non-functional. I called the Medtronic lady because nobody was getting back to me about whether to fix it, keep it in, or take it out. My dad said to turn it off, but she said to go ahead and keep using it, but the leads need to be replaced. They say the batteries are supposed to last three years, but God knows if that means I'll have to be cut open every year and have a new battery put in.
"In the meantime, I'm walking around with this dead thing in me and my doctor says, 'Well, if we fix it and it breaks again, we'll know it's your job.' Am I supposed to change jobs because of this? Well, I live in Michigan and there are no other jobs. Believe me, I've looked.
Kraft visited LawyersAndSettlements because she was familiar with Sprint Fidelis lead failures and hoped to find answers about the InterStim II leads. "A friend of mine, her father had one of those put in for his heart and he just had to go in and have a lead changed," she says. "I was wondering if they're the same leads. They're trying to blame this on my job and my size, but I'm beginning to wonder if any of their leads are worth a crap.
"I've contacted my doctor and asked for an itemized bill so I can see how much this whole system costs. It's a real money maker for them. All my doctor does from 7:30 AM to 7:30 PM every Thursday is whip these things in. Medtronic isn't going to let it out that there are troubles with this thing and it's not as great as they're making it out to be. Meanwhile it's my body and this thing's bumping around inside me.
"Maybe somebody knows something and knows where to direct me. I'm just that kind of a person—I don't like to get screwed over."