BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL 3 RF HE

    MDR report key: 1253580 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40303
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 8, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    NIK
    Removal / Correction Number
    Z-0863-05
    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 HE IMPLANTABLE CHF GENERATOR NIK CARDIAC PACEMAKERS, INC H217 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other THE DEVICE 4543/119197 WAS IMPLANTED 29-AUG-2006| THE DEVICE 0158/129507 WAS IMPLANTED 05-FEB-2004| THE DEVICE 6482 007793 WAS USED DURING THE EVENT.| THE DEVICE 4471/441629 WAS IMPLANTED 29-AUG-2006