BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL 3

    MDR report key: 1253730 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40081
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Date of Event
    August 30, 2008
    Report Date
    August 30, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    NIK
    Removal / Correction Number
    Z47/53-08
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    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 45 YR Other THE DEVICE 4474/305264 WAS IMPLANTED 30-AUG-2004| THE DEVICE 4046/095804 WAS IMPLANTED 31-AUG-2004