BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY DR HE

    MDR report key: 1043410 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33239
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 7, 2008
    Report Date
    February 7, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    Z1192/94-6
    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 DR HE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T180 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other THE DEVICE 0185/137613 WAS IMPLANTED 05-JUL-2006| THE DEVICE 0085/102045 WAS IMPLANTED 01-NOV-2006