BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY EL

    MDR report key: 1253676 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40563
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 15, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    Z47/53-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY EL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T127 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other THE DEVICE 0185/100104 WAS IMPLANTED 26-MAR-2004| THE DEVICE 4470/413333 WAS IMPLANTED 26-MAR-2004| THE DEVICE E030/505983 WAS IMPLANTED 15-SEP-2008