BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL TR

    MDR report key: 2170025 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-10259
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 2, 2011
    Report Date
    July 18, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NKE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LABORATORY ANALYSIS WAS COMPLETED. 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 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.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, INITIAL ANALYSIS INDICATED ERI WAS TRIGGERED WHILE IMPLANTED, THIS DEVICE PASSED THE LONGEVITY CALCULATION, AND THERE WERE NO FAULT CODES, RESETS OR ERRORS NOTED. THIS DEVICE, HOWEVER, FAILED THE FUNCTIONAL MATE TESTING. ONCE ANALYSIS IS COMPLETE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS RETURNED FOR DISPOSAL. THERE WERE NO ALLEGATIONS AGAINST THE DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL TR IMPLANTABLE CHF GENERATOR NKE GUIDANT CRM CLONMEL IRELAND H145

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR 4517| H145