BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROFILE MD V-186 SERIES TIERED THERAPY DEFIBRILLATOR

    MDR report key: 540167 · Received August 18, 2004

    Report

    Report Number
    2938836-2004-00450
    Event Type
    Death
    Date Received
    August 18, 2004
    Date of Event
    June 4, 2004
    Report Date
    June 4, 2004
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO ST. JUDE MEDICAL THAT THE DEVICE WAS RETURNED DUE TO ERI, 35 MONTHS AFTER IMPLANT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other THERAPY DATES: NA