BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY DS

    MDR report key: 1043059 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33588
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 13, 2008
    Report Date
    February 18, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    Z47/55-07
    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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T125 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other THE DEVICE 0041/117904 WAS IMPLANTED 04-JAN-1991| THE DEVICE 4193/BAA005 WAS IMPLANTED 13-JUN-2002| THE DEVICE 0020/101573 WAS IMPLANTED 04-JAN-1991| THE DEVICE 4312/043078 WAS IMPLANTED 04-JAN-1991| THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE 6481 015189 WAS USED DURING THE EVENT.| THE DEVICE 4312/043076 WAS IMPLANTED 04-JAN-1991| THE DEVICE 6947/TDG014 WAS IMPLANTED 13-JUN-2002