BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY DS VR

    MDR report key: 1041476 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-32060
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    December 29, 2007
    Report Date
    January 24, 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 DS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T135 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other THE DEVICE 6481 024959 WAS USED DURING THE EVENT.| THE DEVICE 0157/121161 WAS IMPLANTED 12-FEB-2004