BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL 3 RF

    MDR report key: 1041503 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-32032
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    December 6, 2007
    Report Date
    January 24, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    NIK
    Removal / Correction Number
    Z47/55-07
    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 56 YR Other THE DEVICE 4402/BIU222 WAS IMPLANTED 18-MAY-2007| THE DEVICE 6482 004089 WAS USED DURING THE EVENT.| THE DEVICE 4513/300367 WAS IMPLANTED 13-NOV-2002| THE DEVICE 0125/309067 WAS IMPLANTED 08-JUL-1998| THE DEVICE 4402/BIU242 WAS IMPLANTED 18-MAY-2007| THE DEVICE 4047/119510 WAS IMPLANTED 18-MAY-2007| THE DEVICE 4047/119511 WAS IMPLANTED 18-MAY-2007