BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVIAN RF HE - IS-1/DF-1/LV-1

    MDR report key: 1253719 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40450
    Event Type
    Injury
    Date Received
    November 11, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 2, 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 LIVIAN RF HE - IS-1/DF-1/LV-1 IMPLANTABLE CHF GENERATOR NIK CARDIAC PACEMAKERS, INC H229 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention THE DEVICE 0181/111686 WAS IMPLANTED 14-AUG-2008| THE DEVICE 6482 038383 WAS USED DURING THE EVENT.| THE DEVICE 6487 507040 WAS USED DURING THE EVENT.| THE DEVICE 6483 507020 WAS USED DURING THE EVENT.| THE DEVICE 4136/282815 WAS IMPLANTED 14-AUG-2008| THE DEVICE 4518/324940 WAS IMPLANTED 14-AUG-2008