BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2 DR

    MDR report key: 1043433 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33206
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 6, 2008
    Report Date
    February 6, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    Z47/53-08
    Adverse Event
    Yes
    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 DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T165 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention THE DEVICE 6481 047491 WAS USED DURING THE EVENT.| THE DEVICE 4469/448593 WAS IMPLANTED 22-AUG-2005| THE DEVICE 0185/120714 WAS IMPLANTED 22-AUG-2005