BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1254086 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40935
    Event Type
    Injury
    Date Received
    November 11, 2008
    Date of Event
    September 25, 2008
    Report Date
    September 25, 2008
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    NIK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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 N119 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention THE DEVICE N119/ WAS IMPLANTED| THE DEVICE N119/ WAS IMPLANTED