BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROFILE MD V-186 SERIES TIERED THERAPY DEFIB.

    MDR report key: 489583 · Received October 7, 2003

    Report

    Report Number
    2938836-2003-00477
    Event Type
    Death
    Date Received
    October 7, 2003
    Date of Event
    July 30, 2003
    Report Date
    July 30, 2003
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO ST. JUDE MEDICAL THAT THE PATIENT EXPIRED, CAUSE UNKNOWN. A LOW LEAD IMPEDANCE WAS OBSERVED ON STORED DIAGNOSTICS. THE PHYSICAN SUSPECTED THE DEVICE MAY HAVE DELIVERED THERAPY INTO A LOW IMPEDANCE LOAD, THEREBY DAMAGING THE ICD. THE ICD AND LEAD WERE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFILE MD V-186 SERIES TIERED THERAPY DEFIB. IMPLANTABLE CARDIAC DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD V-186HV3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Death SP02, THERAPY DATES: NA.