BEUDAMED
    FDA Adverse Event Death Summary report: N

    ST JUDE MEDICAL

    MDR report key: 707643 · Received April 20, 2006

    Report

    Report Number
    MW1038796
    Event Type
    Death
    Date Received
    April 20, 2006
    Date of Event
    March 2, 2006
    Report Date
    April 20, 2006
    Manufacturer
    ST JUDE MEDICAL
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PACEMAKER/DEFIBRILLATOR FIRED 2 TIMES NOTED BY WIFE. IT HAD PREVIOUSLY FIRED 13 DAYS EARLIER WITH MUCH STRONGER AND CONTINUED/REPEATING SHOCKS -10+-. SHOCKS ON EVENT DATE WERE NOT SUFFICIENT TO RETURN HEART TO NORMAL RHYTHM. ECG'S FROM CARDIAC REHAB 9 HOURS EARLIER SHOWED NO ABNORMAL RHYTHMS. PT WAS ASYTOLIC & NOT BREATHING WHEN PARAMEDICS ARRIVED. TRANSPORTED & PRONOUNCED @ 9:09. PACEMAKER/DEFIBRILLATOR NOT INTERROGATED AT HOSP. PACEMAKER/DEFIBRILLATOR APPEARS TO HAVE BEEN REMOVED AT SOME TIME BETWEEN DEATH AND CREMATION BUT IS UNACCOUNTED FOR. HOSP ORGAN RECOVERY TEAM -NOT HEART OR ANY ORGANS IN CHEST AREA HARVESTED-, FUNERAL HOME ALL DENY ANY KNOWLEDGE OF WHAT HAPPENED TO DEVICE. SO ANY DATA TO SUPPORT OR REFUTE THE DEVICES AS THE CAUSE OR UNABLE TO PREVENT CAUSE OF PT'S DEATH IS PRESENTLY UNOBTAINABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL PACEMAKER/DEFIBRILLATOR, BIVENTRICULAR NIK ST JUDE MEDICAL V-343 *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death