BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVIAN

    MDR report key: 1771466 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12497
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 11, 2010
    Report Date
    June 11, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVISION PROCEDURE WAS PERFORMED. THE POCKET WAS REOPENED, AND IT WAS DISCOVERED THAT THE RV DEFIBRILLATION LEAD'S TERMINAL PINS WERE REVERSED IN THE HEADER. THE LEAD WAS RECONNECTED IN THE PROPER CONFIGURATION, AND THE POCKET WAS CLOSED. CURRENT RECORDS SUGGEST THAT THIS DEVICE AND RV LEAD REMAIN IMPLANTED AND IN SERVICE. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD WERE EXHIBITING NOISE ON THE RV RATE/SENSE AND SHOCK CHANNELS. LEAD IMPEDANCE MEASUREMENTS WERE STABLE. THE PATIENT IS PACEMAKER DEPENDANT, AND EXPERIENCED SYNCOPAL EPISODES DUE TO PACING INHIBITION FROM THE NOISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIVIAN IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H229

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening| R H229| H175| 4517| 0185| 4087