BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVIAN

    MDR report key: 2910558 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15639
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 14, 2012
    Report Date
    February 22, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, TECHNICIANS USED AN ENGINEERING-LEVEL LONGEVITY PREDICTION CALCULATION TO ASSESS THE RATE OF BATTERY DEPLETION, GIVEN THE PROGRAMMED PARAMETERS AND OTHER DATA STORED WITHIN THE MEMORY OF THE DEVICE. THE RESULTS OF THIS CALCULATION INDICATED THAT THE ACTUAL RATE OF BATTERY DEPLETION FELL WITHIN AN ACCEPTABLE RANGE. NEXT, A COMPREHENSIVE SERIES OF DIAGNOSTIC TESTS WERE CONDUCTED THAT VERIFIED THE PERFORMANCE OF THERAPY DELIVERY, SENSING, AND RECORDING FUNCTIONS. HAVING MET THE ENGINEERING LONGEVITY PREDICTION, FUNCTIONALLY PASSING ALL RETURNED PRODUCT TESTING, AND WITH NO FURTHER INFORMATION TO INDICATE A PRODUCT PERFORMANCE ISSUE, WE HAVE CONCLUDED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE BATTERY DEPLETED WITHIN THIRTY SIX MONTHS OF IMPLANT. A REVIEW OF DEVICE MEMORY REVEALED SEVERAL ANTI-TACHYCARDIA EPISODES. IT WAS THOUGHT THESE EPISODES WERE DUE TO OVERSENSING NOISE THAT RESULTED IN INAPPROPRIATE SHOCK AND ANTITACHYCARDIA PACING THERAPY. THERE WAS CONCERN THE BATTERY DEPLETED MORE RAPIDLY THAN EXPECTED. A REPLACEMENT PROCEDURE WAS PERFORMED. THIS DEVICE WAS REMOVED, REPLACED AND RETURNED FOR ANALYSIS. UPON REMOVAL, VISUAL INSPECTION OF THE RIGHT VENTRICULAR LEAD REVEALED INSULATION DAMAGE THOUGHT DUE TO THE PLACEMENT OF THE LEAD IN THE PACEMAKER POCKET. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17591 LIVIAN IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H240

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R