BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2 DR

    MDR report key: 944815 · Received November 8, 2007

    Report

    Report Number
    2124215-2007-25855
    Event Type
    Malfunction
    Date Received
    November 8, 2007
    Date of Event
    August 10, 2006
    Report Date
    August 23, 2007
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    Z1288/92-6
    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 68 YR Other