BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL 3

    MDR report key: 1041419 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-32115
    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
    Z47/53-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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 68 YR Other THE DEVICE 4542/103654 WAS IMPLANTED 22-MAR-2005| THE DEVICE 0125/330504 WAS IMPLANTED 26-JAN-2000| THE DEVICE 4470/461783 WAS IMPLANTED 22-MAR-2005