BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL 3 RF

    MDR report key: 1041566 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-31983
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    September 11, 2007
    Report Date
    February 18, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    NIK
    Removal / Correction Number
    Z-0863-05
    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 CONTAK RENEWAL 3 RF IMPLANTABLE CHF GENERATOR NIK CARDIAC PACEMAKERS, INC H215 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other THE DEVICE 0184/118472 WAS IMPLANTED 30-NOV-2005| THE DEVICE 4469/455488 WAS IMPLANTED 30-NOV-2005| THE DEVICE 4518/311035 WAS IMPLANTED 30-NOV-2005| THE DEVICE 6482 002267 WAS USED DURING THE EVENT.| THE DEVICE 6482 015887 WAS USED DURING THE EVENT.