BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL 3 RF

    MDR report key: 1041585 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-31946
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    January 17, 2007
    Report Date
    January 3, 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 H210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other THE DEVICE 4440/719070 WAS IMPLANTED 26-NOV-1997| THE DEVICE 0125/225845 WAS IMPLANTED 26-NOV-1997| THE DEVICE 6482 007355 WAS USED DURING THE EVENT.| THE DEVICE LATR 27073 WAS USED DURING THE EVENT.| THE DEVICE 4549/151896 WAS IMPLANTED 27-SEP-2006