BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL 3 RF HE

    MDR report key: 1041541 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-31986
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    September 12, 2007
    Report Date
    March 24, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    NIK
    Removal / Correction Number
    NA
    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 77 YR Other THE DEVICE 0148/137908 WAS IMPLANTED 29-APR-2004| THE DEVICE H177/101062 WAS IMPLANTED 29-APR-2004| THE DEVICE 4538/150536 WAS IMPLANTED 30-DEC-2003