BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY EL

    MDR report key: 1042164 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34483
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 17, 2008
    Report Date
    March 17, 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 53 YR Required Intervention THE DEVICE 4479/314509 WAS IMPLANTED 23-FEB-2004| THE DEVICE 6481 035584 WAS USED DURING THE EVENT.| THE DEVICE 0147/114317 WAS IMPLANTED 23-FEB-2004