BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1253952 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40699
    Event Type
    Injury
    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
    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/LV-1 IMPLANTABLE CHF PULSE GENERATOR NIK CARDIAC PACEMAKERS, INC N118 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention THE DEVICE 4513/311663 WAS IMPLANTED 26-FEB-2003| THE DEVICE N119/ WAS IMPLANTED| THE DEVICE H215/708730 WAS IMPLANTED 23-OCT-2007| THE DEVICE 0158/112077 WAS IMPLANTED 26-FEB-2003