BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2 DR

    MDR report key: 1042195 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34458
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 16, 2008
    Report Date
    March 16, 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 64 YR Required Intervention THE DEVICE 4086/221046 WAS IMPLANTED 21-JUN-2005| THE DEVICE 0184/112981 WAS IMPLANTED 21-JUN-2005