BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROFILE MD V-186 SERIES TIERED THERAPY DEFIB.

    MDR report key: 458605 · Received May 6, 2003

    Report

    Report Number
    2938836-2003-00174
    Event Type
    Death
    Date Received
    May 6, 2003
    Date of Event
    January 4, 2003
    Report Date
    January 4, 2003
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO ST. JUDE MEDICAL IN 2003. THE ONLY INFO GIVEN AT THAT TIME WAS THAT THE PT HAD EXPIRED.

    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 61 YR Death LEAD, MODEL SP01.