BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONTOUR MD V-175AC SERIES TIERED THERAPY DEFIB.

    MDR report key: 464710 · Received June 5, 2003

    Report

    Report Number
    2938836-2003-00237
    Event Type
    Death
    Date Received
    June 5, 2003
    Date of Event
    April 29, 2003
    Report Date
    April 29, 2003
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHILE LIFTING WEIGHTS AT THEIR LIVING FACILITY, THE PATIENT PRESENTED TO THE INFIRMARY CLUTCHING THEIR CHEST AND COMPLANING OF CHEST PAIN AS THEIR DEFIBRILLATOR WAS GOING OFF. THE PHYSICIAN PRESENT WITNESSED THE DEFIBRILLATOR FIRE APPROXIMATELY SIX TO EIGHT TIMES DURING AN 18-MINUTE PERIOD JUST PRIOR TO THE PATIENT BECOMING UNRESPONSIVE AND REQUIRING CPR. THE PATIENT HAD PRESENTED TO THEIR PHYSICIAN FOR A CHECK-UP THE DAY PRIOR TO THEIR DEATH BECAUSE THE DEFIBRILLATOR HAD DELIVERED THERAPY 4 MONTHS BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR MD V-175AC SERIES TIERED THERAPY DEFIB. IMPLANTABLE CARDIAC DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD V-175AC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death THERAPY DATES: NA.| LEAD MODEL SP02,