BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRIZM HE DR

    MDR report key: 1041558 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-31975
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    August 16, 2007
    Report Date
    February 22, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    LAY USER/PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRIZM HE DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC 1853 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other THE DEVICE 6947/TDG104 WAS IMPLANTED 21-APR-2004