BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL TR 2

    MDR report key: 1042116 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34519
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 18, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    NKE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    LAY USER/PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL TR 2 IMPLANTABLE CHF GENERATOR NKE CARDIAC PACEMAKERS, INC H145 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other THE DEVICE 4096/125447 WAS IMPLANTED 04-DEC-2006| THE DEVICE 4097/111772 WAS IMPLANTED 04-DEC-2006| THE DEVICE 4517/423645 WAS IMPLANTED 04-DEC-2006