BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2 VR EL

    MDR report key: 1042270 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34365
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 12, 2008
    Report Date
    March 12, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    Z47/55-07
    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 2 VR EL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T177 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other THE DEVICE 6481 002899 WAS USED DURING THE EVENT.| THE DEVICE 0155/202320 WAS IMPLANTED 31-MAR-2000