BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY DS

    MDR report key: 1042009 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34636
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 20, 2008
    Report Date
    March 20, 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
    LAY USER/PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY DS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T125 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other THE DEVICE 0185/125191 WAS IMPLANTED 12-JUL-2005| THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE 6481 013514 WAS USED DURING THE EVENT.