BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS HE IS-1/DF-1/IS-1

    MDR report key: 1253793 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40676
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 18, 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 COGNIS HE IS-1/DF-1/IS-1 IMPLANTABLE CHF PULSE GENERATOR NIK CARDIAC PACEMAKERS, INC N119 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other THE DEVICE 0185/201318 WAS IMPLANTED 17-SEP-2008| THE DEVICE 4592/111260 WAS IMPLANTED 17-SEP-2008| THE DEVICE 4470/605263 WAS IMPLANTED 17-SEP-2008