BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY DS

    MDR report key: 1042723 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33922
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 27, 2008
    Report Date
    February 27, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    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 DS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T125 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention THE DEVICE 4469/492891 WAS IMPLANTED 11-FEB-2008| THE DEVICE 6481 023839 WAS USED DURING THE EVENT.| THE DEVICE 6481 056852 WAS USED DURING THE EVENT.| THE DEVICE 0154/346031 WAS IMPLANTED 29-MAR-2001