BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL 3

    MDR report key: 1254258 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40868
    Event Type
    Injury
    Date Received
    November 11, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 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 IMPLANTABLE CHF GENERATOR NIK CARDIAC PACEMAKERS, INC H170 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention THE DEVICE 6481 306180 WAS USED DURING THE EVENT.| THE DEVICE 4469/449980 WAS IMPLANTED 13-AUG-2005| THE DEVICE 4469/449406 WAS IMPLANTED 11-AUG-2005| THE DEVICE 4542/106486 WAS IMPLANTED 11-AUG-2005| THE DEVICE 0184/108653 WAS IMPLANTED 11-AUG-2005| THE DEVICE 4086/226356 WAS IMPLANTED 13-AUG-2005