BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY DS

    MDR report key: 1043041 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33598
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 18, 2008
    Report Date
    February 18, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    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 DS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T125 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other THE DEVICE 6481 015911 WAS USED DURING THE EVENT.| THE DEVICE 0148/150685 WAS IMPLANTED 14-OCT-2005| THE DEVICE 4470/483760 WAS IMPLANTED 14-OCT-2005