BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRT-D

    MDR report key: 1449324 · Received August 22, 2009

    Report

    Report Number
    MW5012511
    Event Type
    Death
    Date Received
    August 22, 2009
    Date of Event
    July 27, 2009
    Report Date
    August 22, 2009
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INTERNAL DEFIBRILLATOR DID NOT FIRE WHEN HEART WENT INTO A LIFE THREATENING RHYTHM. DIAGNOSIS OR REASON FOR USE: CHF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRT-D IMPLANTED DEFIBRILLATOR LWS BOSTON SCIENTIFIC N118

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death