BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL 3

    MDR report key: 1253837 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40571
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 16, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    NIK
    Removal / Correction Number
    Z47/55-07
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    LAY USER/PATIENT

    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 79 YR Other THE DEVICE 4513/302408 WAS IMPLANTED 31-JUL-2002| THE DEVICE 4087/115990 WAS IMPLANTED 31-JUL-2002| THE DEVICE 0148/113809 WAS IMPLANTED 31-JUL-2002| THE DEVICE 4542/109178 WAS IMPLANTED 12-JUL-2006