BEUDAMED
    FDA Adverse Event Summary report: N

    IMPLANTABLE CHF GENERATOR

    MDR report key: 1254025 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40884
    Date Received
    November 11, 2008
    Report Date
    August 4, 2010
    Product Code
    NIK
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. AN ENGINEERING LEVEL LONGEVITY PREDICTION CALCULATION WAS USED 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 INDICATE THAT THE ACTUAL RATE OF BATTERY DEPLETION FELL WITHIN AN ACCEPTABLE RANGE. BATTERY CONSUMPTION WAS COMPARED TO ACTUAL CLINICAL USAGE AND A NORMAL CURRENT CONDITION WAS VERIFIED. NEXT, A SERIES OF DIAGNOSTIC TESTS WERE CONDUCTED TO VERIFY THE PERFORMANCE OF PACING, SENSING, AND RECORDING FUNCTIONS. HAVING MET THE ENGINEERING LONGEVITY PREDICTION AND FUNCTIONALLY PASSING ALL RETURNED PRODUCT TESTING, WE HAVE CONCLUDED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    TECHNICAL SERVICES ADVISED THAT THE DEVICE FOLLOW-UP INTENSIFY TO MONTHLY. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE AND RECORDS INDICATE THAT THIS DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED. SUBSEQUENTLY, THIS DEVICE WAS EXPLANTED AND RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. ANALYSIS OF THE DEVICE IS CURRENTLY IN PROGRESS. THIS EVENT WILL BE UPDATED AS ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), WHICH WAS PART OF THE SHORTENED REPLACEMENT WINDOW ADVISORY, ORIGINALLY COMMUNICATED (B)(6), 2007, HAD A MONITORING BATTERY VOLTAGE OF 2.65 V AFTER 27 MONTHS OF IMPLANT, A MONITORING VOLTAGE OF 2.59 V AFTER 30 MONTHS OF IMPLANT, AND A MONITORING VOLTAGE OF 2.58 V AFTER 33 MONTHS OF IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTABLE CHF GENERATOR NIK

    Patients

    Seq Age Sex Outcome Treatment
    1 THE DEVICE 6482 002183 WAS USED DURING THE EVENT.| THE DEVICE 6483 505100 WAS USED DURING THE EVENT.| THE DEVICE 0180/101185 WAS IMPLANTED 14-DEC-2005| THE DEVICE 4088/215404 WAS IMPLANTED 22-NOV-2005| THE DEVICE 6487 505100 WAS USED DURING THE EVENT.| THE DEVICE 4549/151891 WAS IMPLANTED 14-DEC-2005