Medtronic Stops Selling Faulty Defibrillators

Medtronic is “recalling” its latest heart defibrillator models because of faulty wiring, which could lead to either it not working when you most need it, or it shocking you randomly in the heart with painful electric jolts. “The company is urging all of the roughly 235,000 patients with the lead, known as the Sprint Fidelis, to see their doctors to make sure it has not developed a fracture that can make the device misread heart-rhythm data.”

If you’ve had a defibrillator put in since 2004 and it was a Medtronic model, odds are it’s using the Fidelis lead. Unfortunately, replacing the lead is no easy task, but the odds your implant is a bum one is fairly small: as of right now Medtronic estimates “that about 2.3 percent of patients with the Fidelis lead, or 4,000 to 5,000 people, would experience a lead fracture within 30 months of implantation.”

Vice President Dick Cheney has a Medtronic heart implant, but according to the article, his is an earlier model and therefore cannot explain his grimaces.

“Patients Warned as Maker Halts Sale of Heart Implant Part” [New York Times]
(Photo: Getty)

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  1. XTC46 says:

    yikes. In this kind of recall I hope they are calling every single patient with one of these in them.

  2. DTaylor404 says:

    Speaking as one who was implanted with a Medtronic defibrillator (ICD) in June of this year: In my own case, I was scheduled for a three-month programming check and test-fire, and will return to the cardiac center for downloading of the ICD’s data logs every six months thereafter. (In addition to its defib capability, the unit is a 24/7 heart monitor.) So, yes, there are plenty of opportunities to inform the patients of any potential problems.

    In fact, when I went in for my three-month check, they found stray noise in the line. It hadn’t caused the device to fail, and wasn’t expected to, but they’re going to replace the lead anyway.

  3. rbb says:

    Great picture!

  4. tph says:

    The title of this post is slightly off, it’s not defibs that are being recalled here but leads which are the cables that connect the defibs to the heart.

    Unfortunately, leads are far more painful and difficult to replace than the defibs themselves.

  5. Anonymous says:

    The lead is not being recalled but is being voluntarily pulled from the market by Medtronic. There is a huge difference. The issue was discovered by Medtronic (not the FDA). The issue with the lead is not even statistically relevant.

    Every patient with a Sprint Fidelis lead received a letter from their doctor.

    The fact of the matter is that devices and device systems save lives every single day. Chances are if you have one it will save your life one day. It is important to stay informed, but also to keep it in perspective.

    I wouldn’t hesitate to have a Medtronic product implanted.

  6. CurbRunner says:

    These things sound like implanted Tasers to me.
    I hope the cops don’t figure out how to use these things via remote control.

  7. FLConsumer says:

    @CurbRunner: I’d be curious to see how one of these things holds up to a taser, assuming it wouldn’t be good.

    Things like this make me feel VERY happy I’ve refused to get a pacemaker each time the cardiologist brings it up. Sure, my heart stops periodically, but it always restarts itself. It doesn’t feel great, but it doesn’t interfere with my life. Medical literature confirms no one has died from my particular cardiovascular condition, but the cardiologist sure loves pushing the issue at every single appointment…for the past 10 years. I’m not even 30 yet.

    I don’t doubt that these devices save lives and are absolute blessings for some, but I do question the frequency of which they are installed. It seems like such a sledgehammer approach when other options exist.

  8. moeman1024 says:

    Ok, enough is enough. I have went through three surgeries already because of this company and recalls. Two defibrillator/pacemakers recalled and another wire issue. The battery died on the first two then the wire cracked giving to much noise.
    This is icing on the cake another surgery for a problem caused by a cheap company. On top of this my heart problems are a result of a doctors mistake.
    I will be calling the doctor in the morning.

    Thank you for the warning.

  9. DTaylor404 says:

    @DTaylor404: Updating my own comment: As I implied but didn’t quite say, my doctor made the decision to replace my lead before receiving any letter from Medtronic–although he had spoken to one of their representatives. The doctor had mentioned his intent to address the issue via the unit’s programming (which the Reuters/NYTimes article says is effective in most cases), but Medtronic said “Better safe than sorry; Go ahead and replace it.”

    I won’t say it isn’t inconvenient to go into surgery again, and (as it was just yesterday) my shoulder does ache — percoset is my friend — but all in all, it seems that both my doctor and Medtronic are handling the problem exactly as I would wish.

  10. DTaylor404 says:

    @CurbRunner: They don’t compare to tasers at all. I was awake for the final test-fire of the thing in surgery yesterday. As advertised, it feels no worse than a good solid punch to the chest. The jolt a taser delivers is meant to be incapacitating.

  11. moeman1024 says:

    Huh, seems all my comments seem to disappear.