BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 1953979 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24218
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 19, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS EXPLANTED OVER A YEAR LATER FOR NORMAL BATTERY DEPLETION AND KNOWN HIGHER PROGRAMMED THRESHOLDS. A RETURN REQUEST WAS MADE FOR THIS DEVICE. 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.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE WAS OPERATING IN THE SECOND TO HIGHEST CURRENT BIN DUE TO THE HIGH OUTPUT SETTINGS IN THE VENTRICLE. THE DEVICE IS IN ELECTIVE REPLACEMENT NEAR (ERN) WHICH USUALLY MEANS IT HAS LESS THAN ONE YEAR OF REMAINING LONGEVITY. BASED ON THE CURRENT PROGRAMMED PARAMETERS AND PACING RATES IT APPEARED THAT THE DEVICE MAY BE DEPLETING FASTER THAN EXPECTED. IN THE PAST AUTO CAPTURE WAS PROGRAMMED ON IN THE DEVICE AND THE THRESHOLDS WERE RELATIVELY HIGH. HOWEVER, IT WAS ALSO UNKNOWN WHAT OTHER PROGRAMMED PARAMETER VALUES AND PACING PERCENTAGES WERE MADE PRIOR. IN CONCLUSION, THE DEVICE APPEARED TO BE FUNCTIONING PROPERLY HOWEVER ERN WAS SET WHICH MEANS IT MAY ONLY HAVE ONE YEAR OF REMAINING LONGEVITY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WAS INQUIRING ABOUT LONGEVITY AND DEVICE OPERATION. AS A RESULT A SAVE TO DISK WAS SENT TO ENGINEERS FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR 4016| 1290| 4017| 1283