BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL 3

    MDR report key: 1043125 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33514
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 14, 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 H175 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other THE DEVICE 6481 004235 WAS USED DURING THE EVENT.| THE DEVICE 4517/415799 WAS IMPLANTED 16-FEB-2005| THE DEVICE 6487 506020 WAS USED DURING THE EVENT.| THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE 4470/457062 WAS IMPLANTED 16-FEB-2005| THE DEVICE 6483 506010 WAS USED DURING THE EVENT.| THE DEVICE 0185/115533 WAS IMPLANTED 16-FEB-2005| THE DEVICE LATR 44382 WAS USED DURING THE EVENT.