BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2 DR

    MDR report key: 1254091 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40892
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 24, 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 2 DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T165 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other THE DEVICE 6481 045894 WAS USED DURING THE EVENT.| THE DEVICE 0184/122418 WAS IMPLANTED 11-JUN-2007| THE DEVICE 4054/454978 WAS IMPLANTED 11-JUN-2007