BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL 3 RF

    MDR report key: 1041423 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-32119
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    January 3, 2008
    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 H215 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other THE DEVICE 0184/117874 WAS IMPLANTED 30-NOV-2005| THE DEVICE 4086/226613 WAS IMPLANTED 30-NOV-2005| THE DEVICE 4517/421197 WAS IMPLANTED 30-NOV-2005| THE DEVICE 6482 000425 WAS USED DURING THE EVENT.