BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY EL

    MDR report key: 1254225 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-41063
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Date of Event
    September 29, 2008
    Report Date
    September 29, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    Z47/53-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY EL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T127 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other THE DEVICE 6481 014923 WAS USED DURING THE EVENT.| THE DEVICE 0147/115173 WAS IMPLANTED 26-APR-2004| THE DEVICE 4086/201659 WAS IMPLANTED 26-APR-2004