BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONTOUR MD V-175AC SERIES TIERED THERAPY DEFIB.

    MDR report key: 425642 · Received November 1, 2002

    Report

    Report Number
    2938836-2002-00415
    Event Type
    Death
    Date Received
    November 1, 2002
    Date of Event
    July 15, 2002
    Report Date
    July 15, 2002
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2002, THE PATIENT HAD 17 EPISODES, 3 CLASSIFIED AS TACHYCARDIA, 14 AS FIBRILLATION. THE DEVICE DETECTED AND STARTED TO GIVE THERAPIES. THE HIGH VOLTAGE IMPEDANCE WAS ABOVE 200 OHMS. THE AMOUNT OF ENERGY WAS BELOW 27 JOULES. THE PATIENT LOST CONSCIOUSNESS AND WAS RESUSCITATED AND SENT TO A HOSPITAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other THERAPY DATES: NA.