BEUDAMED
    FDA Adverse Event Death Summary report: N

    ST JUDE MEDICAL

    MDR report key: 898065 · Received June 20, 2007

    Report

    Report Number
    898065
    Event Type
    Death
    Date Received
    June 20, 2007
    Date of Event
    May 26, 2007
    Report Date
    June 1, 2007
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT S/P ELECTIVE INSERTION OF BIVAICD EXPIRED FROM CARDIO-PULMONARY ARREST; PRELIMINARY AUTOPSY SHOWED RV LEAD MIGRATED UP SEPTUM AND PERFORATED THROUGH PERICARDIUM CAUSING CARDIAC TAMPONADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL AICD LWS ST. JUDE MEDICAL, INC. V-268 *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death 7001/6S