BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRIZM 2 DR

    MDR report key: 1253642 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40495
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 12, 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 VENTAK PRIZM 2 DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC 1861 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other THE DEVICE 0157/106102 WAS IMPLANTED 05-FEB-2003| THE DEVICE 4087/158520 WAS IMPLANTED 05-FEB-2003