BEUDAMED
    FDA Adverse Event Death Summary report: N

    ST JUDE VICTORY MODEL 5816

    MDR report key: 1343100 · Received March 11, 2009

    Report

    Report Number
    MW5010289
    Event Type
    Death
    Date Received
    March 11, 2009
    Report Date
    March 11, 2009
    Manufacturer
    ST JUDE MFR
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD A DIZZY SPELL IN 2006. DR IMPLANTED A ST. JUDE VICTORY MODEL 5816. FROM DAY ONE, AFTER RETURNING HOME FROM HOSP, PROCEDURE PT COMPLAINED OF SHORTNESS OF BREATH, INABILITY TO BREATHE, RIPPLING IN ABDOMEN AREA. VISITS TO DR'S PROVIDED NO SOLUTION. IN THE FOLLOWING MONTH, PT TAKEN BY AMBULANCE TO HOSP, UNABLE TO BREATH. PLACED ON RESPIRATOR, SPENT TWO WEEKS IN ICU. RETURNED HOME, SAME PROBLEMS, UNABLE TO BREATH. IN 2007, PT DIED IN EMERGENCY ROOM, FIVE MONTHS AFTER PACEMAKER IMPLANT. CAUSE OF DEATH "CONGESTIVE HEART FAILURE" ...PT NEVER HAD ANY SYMPTOMS OF HEART FAILURE, BEFORE THE PACEMAKER IMPLANT NOR WAS HE ON ANY MEDICATION FOR HEART FAILURE. DRS NEVER DISCUSSED ANY PACEMAKER RISKS BEFORE THE PROCEDURE WAS DONE. DOESN'T THE FDA HAVE ANY CONTROL OVER THESE DEVICES? SINCE PT'S DEATH, I HAVE DISCOVERED MANY REPORTS OF HEART FAILURE DEATHS IN PTS WITHIN MONTHS OF THE PACEMAKER IMPLANT, PTS THAT NEVER HAD HEART FAILURE SYMPTOMS PRIOR TO THEIR IMPLANTS. THESE DEVICES ARE DANGEROUS AND ARE THE CAUSE OF DEATH IN PTS AND SHOULD BE MORE CLOSELY MONITORED AND CONTROLLED BY THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE VICTORY MODEL 5816 PACEMAKER DXY ST JUDE MFR VICTORY 5816

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death