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Your Voices Have Been Heard!


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Lisa Salberg Find out more about Lisa Salberg
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  • Your Voices Have Been Heard!

    from AP

    The U.S. Food and Drug Administration will recall more than 38,000 faulty cardiac defibrillators manufactured by Guidant Corp. because of potential malfunctions in the devices. The faulty devices have been implanted into patients, the company said Friday.

    Indianapolis-based Guidant said Friday it was voluntarily advising physicians about the safety of several defibrillator models and that regulators had indicated the move would be classified as a recall.
    The devices have failed at least 45 times and have caused at least two deaths as recently as May 30, the company said. Guidant came under fire this spring after reports that Guidant failed to alert physicians about potential problems with the Ventak Prizm 2 DR model defibrillator.
    Guidant said patients implanted with the device should continue to see their doctors at three-month intervals and any patient who recently received a defibrillator shock should consult with their physician.
    ``Patient safety is paramount and our highest priority,'' Guidant CEO Ronald W. Dollens said in a statement. ``Guidant takes seriously its responsibility to create the most reliable products and services, enhance patient outcome and limit adverse events to patients.''
    FDA officials did not immediately return messages.
    Implanted defibrillators shock the heart back into a normal rhythm when it starts beating irregularly. Friday's recall includes the Prizm 2 DR, the Contak Renewal and Contak Renewal 2, the Ventak Prizm AVT, Vitality AVT, Renewal 3 AVT and Renewal 4 AVT ICDs.
    Shares of Guidant fell 80 cents, or 1.1 percent, to $72.86 in afternoon trading on the New York Stock Exchange, where they have traded in a 52-week range of $49.95 to $75.15.
    Guidant shareholders in April voted overwhelmingly in favor of Johnson & Johnson's planned $25.4 billion acquisition of Guidant. The merger, which still must win regulatory approval in the United States and Europe, would be the largest business deal in the 119-year history of New Brunswick, N.J.-based health care products giant J&J. J&J has said it expects to complete the acquisition during the third quarter.
    Johnson & Johnson did not immediately return a message.
    Knowledge is power ... Stay informed!
    YOU can make a difference - all you have to do is try!

    Dx age 12 current age 46 and counting!
    lost: 5 family members to HCM (SCD, Stroke, CHF)
    Others diagnosed living with HCM (or gene +) include - daughter, niece, nephew, cousin, sister and many many friends!
    Therapy - ICD (implanted 97, 01, 04 and 11, medication
    Currently not obstructed
    Complications - unnecessary pacemaker and stroke (unrelated to each other)

  • #2
    Lisa thanks for the update

    Are they still going by serial numbers for the recall that is what they said to my doctor not dates just serial numbers and they told my doctor mine wasn't on the list

    Diagnosed 2003
    Myectomy 2-23-2004
    Husband: Ken
    Son: John diagnosed 2004
    Daughter: Janet (free of HCM)

    Grandchildren: Drew 15,Aaron 13,Karen 9,Connor 9


    • #3
      Re: Your Voices Have Been Heard!

      "Patient safety is paramount and our highest priority,'' Guidant CEO Ronald W. Dollens said in a statement. "Guidant takes seriously its responsibility to create the most reliable products and services, enhance patient outcome and limit adverse events to patients.''
      What a crock of horsesh*t. They're a business, just like any other, and their goal is to make as much money as possible. Only after some poor kid dies because of their negligence, and Guidant is forced to recall these devices after dragging their freaking heels all this time... now 'ol Ronnie the CEO wants to talk all this flowery crap about how his company has only ever been interested in their customers' welfare. Somebody ought to string that bonehead up by his nads and let him feel what it's like to have his future in someone else's hands.

      ...I'm just saying.

      "Some days you're the dog... some days you're the hydrant."


      • #4
        ...not to mention the vaccine industry, in cahoots with the FDA and CDC, which has known for awhile that the mercury-based preservative they've been using in vaccines for children is linked to autism! It seems the "autism epidemic" is linked to the drastically increased number of vaccinations given to children during the 90's.

        --Living life on the edge .. of a continent!
        Charter member: Tinman Club


        • #5
          When I mentioned yesterday to my EP about the cost to change out my devise she said, "OH, Guidant is going to pay for this , don't you even concern yourself with that." I recieved a registered letter today from the hiospital where she practices informing me once agian about my devise and need to follow up asap. Boy this must be a a real bad one!!!

          Dx @ 47 with HOCM & HF:11/00
          Guidant ICD:Mar.01, Recalled/replaced:6/05 w/ Medtronic device
          Lead failure,replaced 12/06.
          SF lead recall:07,extracted leads and new device 2012
          [email protected] Tufts, Boston:10/5/03; age 50. ( [email protected] 240 mmHg ++)
          Paroxysmal A-Fib: 06-07,2010 controlled w/sotalol dosing
          Genetic mutation 4/09, mother(d), brother, son, gene+
          Mother of 3, grandma of 3:Tim,27,Sarah,33w/6 y/o old Sophia, 5 y/o Jack, Laura 34, w/ 5 y/o old Benjamin


          • #6
            I don't know I'm getting quite disguisted at how this has all been handled. At, least in my situation. My local guys are blowing it off saying that nothing is wrong. And the EP nurse I spoke with in Boston seemed quite unsure. I think at this point it feels useless to me. What piece of mind am i getting. You know I got the device because v-fib could happen it was supposed to give me peace of mind. But now not only do I have to worry about the v-fib I now have to worry about the AICD not working. I think if I could at this point I'd rip the thing out and throw it on the cardio's desk and let what-ever-happens happen. I mean to them I'm not that sick anyway.

            I don't know I'm just tired of fighting the people who are supposed to help me!

            Mary S.


            • #7
              Dear Mary,

              Guidant has just turned the issue into a full-blown recall so they have to pay for the device but I don't know about the implantation costs, but since it is an official recall, I think insurance has to cover it.

              I think Lisa has posted the recall story on another thread. Guidant's web site has not been updated to reflect the recall yet but calling them on Monday may help get you started.

              The odds are very low of anything happening, really. Hang in there.