BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL 3 HE IS-1/DF-1/IS-1

    MDR report key: 1389757 · Received May 8, 2009

    Report

    Report Number
    2124215-2009-02086
    Event Type
    Malfunction
    Date Received
    May 8, 2009
    Date of Event
    January 27, 2009
    Report Date
    March 11, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z-1192-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, LABORATORY TECHNICIANS UTILIZED 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 PACING, 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 CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), WHICH IS PART OF THE SHORTENED REPLACEMENT WINDOW PRODUCT ADVISORY INITIALLY COMMUNICATED ON 4/5/2007, REACHED A MONITORING VOLTAGE MEASUREMENT OF 2.85 VOLTS ON (B)(6) 2009, HAVING REACHED 2.65 VOLTS BETWEEN (B)(6) 2008 (27 MONTHS WAS IN (B)(6) 2008). THE HEALTH CARE PERSONNEL SUSPECTED THAT THIS DEVICE WAS DEPLETING EARLY, AND WAS WONDERING IF THE DEVICE SHOULD BE MONITORED WITH INCREASED FOLLOW UPS. THE TECHNICAL SERVICES CONSULTANT DISCUSSED THE SRW ADVISORY AND MONITORING. THE HEALTH CARE PERSONNEL INDICATED THAT THE PATIENT WOULD POSSIBLY BE ENROLLED IN (B)(6) AND THAT THERE WOULD BE NO INCREASE IN FOLLOW UPS AT THIS TIME. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS ASSOCIATED WITH THESE CLINICAL OBSERVATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL 3 HE IS-1/DF-1/IS-1 IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H177 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR