BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY AVT

    MDR report key: 1041870 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34777
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 25, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    Z47/53-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY AVT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC A135 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other THE DEVICE 0157/111834 WAS IMPLANTED 19-JUN-2003| THE DEVICE 4470/360796 WAS IMPLANTED 19-JUN-2003