BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL 3

    MDR report key: 1042629 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34012
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 29, 2008
    Report Date
    February 29, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    NIK
    Removal / Correction Number
    Z47/53-08
    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 IMPLANTABLE CHF GENERATOR NIK CARDIAC PACEMAKERS, INC H179 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other THE DEVICE 4517/417145 WAS IMPLANTED 19-MAY-2005| THE DEVICE 0185/102658 WAS IMPLANTED 03-JUN-2004| THE DEVICE 4470/417015 WAS IMPLANTED 03-JUN-2004| THE DEVICE 4513/312242 WAS IMPLANTED 03-JUN-2004| THE DEVICE 4470/468570 WAS IMPLANTED 19-MAY-2005