BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL 2

    MDR report key: 1041442 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-32096
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    January 2, 2008
    Report Date
    January 2, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    NIK
    Removal / Correction Number
    Z0907/8-05
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    LAY USER/PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL 2 IMPLANTABLE CHF GENERATOR NIK CARDIAC PACEMAKERS, INC H155 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other THE DEVICE M175/200314 WAS IMPLANTED 01-FEB-2008