BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 3043106 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-01730
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 31, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THIS DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    --

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THIS DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER DISPLAYED LONGEVITY CALCULATIONS OF THREE YEARS. LESS THAN ONE YEAR LATER, THE LONGEVITY CALCULATION WAS LESS THAN 6 MONTHS. THE MAGNET RATE WAS 90 PPM AND THE GAS GAUGE WAS ALMOST TO THE ELECTIVE REPLACEMENT INDICATOR (ERI) MARK. AT THIS TIME, THE PATIENT IS BEING MONITORED MONTHLY. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED ANALYSIS OF THE DEVICE MEMORY; HOWEVER, THE PATIENT WAS NO LONGER IN THE CLINIC. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REVEALED THE DEVICE WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION AND REPLACED WITH A NEW DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THE PATIENT HAD THE DEVICE CHECKED AGAIN AND THE GAS GAUGE WAS IN LINE WITH THE TIME PERIOD REPORTED. THE DEVICE WAS REPORTING LESS THAN SIX MONTHS LONGEVITY REMAINING AND THE GAS GAUGE NEEDLE APPEARS CLOSE TO ELECTIVE REPLACEMENT INDICATOR (ERI). BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED REGARDING THIS ISSUE AND INDICATED THEY CAN NOT SAY FOR CERTAIN THAT THE BATTERY PERFORMANCE IS NORMAL, AND REQUESTED DISK ANALYSIS WOULD BE NECESSARY TO CONFIRM. THE MEMORY WAS SAVE TO A DISK AND SUBMITTED FOR ANALYSIS. THE DISK ANALYSIS NOTED NOTHING UNUSUAL. THE DEVICE WAS ON TRACK TO HAVE LESS THAN 6 MONTHS LONGEVITY AND WAS NOT CURRENTLY NEAR A BIN EDGE. ANALYSIS INDICATED THAT THE WHEN THEY SAW THE JUMPINESS, IT MAY HAVE BEEN WHEN RVAC WAS TURNED ON AND IF THE PATIENT HAD BEEN IN RETRY A LOT BEFORE THEY CAME IN TO THE CLINIC, LONGEVITY WOULD BE SHOWING LESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145637 INSIGNIA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR 1388T| KDR701| 1290| 1388TC