BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRIZM 2 DR

    MDR report key: 1042950 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33691
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 20, 2008
    Report Date
    February 20, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    Z0906-05
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 60 YR Other THE DEVICE 1831/106865 WAS IMPLANTED 22-JUL-1999| THE DEVICE 0155/200196 WAS IMPLANTED 22-JUL-1999| THE DEVICE 4054/401391 WAS IMPLANTED 22-JUL-1999