BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVIAN

    MDR report key: 1771620 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-13951
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 9, 2010
    Report Date
    June 9, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE MET SPECIFICATIONS IN TESTING AND ANALYSIS. UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. BASED ON RECORDED DATA FROM DEVICE OPERATIONS AND AN ENGINEERING CALCULATION BASED ON PROGRAMMED VALUES, THIS DEVICE MET LONGEVITY EXPECTATIONS. THE DEVICE WAS THEN PUT THROUGH AND PASSED A SERIES OF AUTOMATED DIAGNOSTIC TESTS THAT VERIFIED THE PERFORMANCE OF THE DEFIBRILLATION, PACING, SENSING, HIGH-VOLTAGE SHOCKING, AND RECORDING FUNCTIONS OF THE DEVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING EXPLANT OF THIS DEVICE FOR NORMAL BATTERY DEPLETION, THE EXPLANTING PHYSICIAN EXPERIENCED DIFFICULTY REMOVING THE ATRIAL LEAD'S TERMINAL PIN. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT (TS) DISCUSSED THE LOCATION OF AN ISOLATED SETSCREW FOR THE ATRIAL RING. THE PHYSICIAN HAD NOT PREVIOUSLY LOCATED THE SETSCREW; THE SETSCREW SUBSEQUENTLY WAS SUCCESSFULLY LOOSENED WITHOUT INCIDENT AND THE LEAD REMOVED. THE DEVICE WAS EXPLANTED AND REPLACED WITH NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIVIAN IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H220

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR 4543| 4555| 4087| H220| 0184