BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2170841 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-11888
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 7, 2011
    Report Date
    August 18, 2011
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    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 AND DISPLAYED NORMAL INDICATOR PROGRESSION. 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, AND FUNCTIONALLY PASSING ALL RETURNED PRODUCT TESTING, WE HAVE CONCLUDED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW VISIT, THE PATIENT WITH THIS DEVICE COMPLAINED OF FATIGUE AND SHORTNESS OF BREATH. THE DEVICE RATE RESPONSE FEATURE WAS PROGRAMMED ON. THE DEVICE WAS CLOSE TO THE ELECTIVE REPLACEMENT TIME (ERT) INDICATOR. FOUR MONTHS LATER, THE DEVICE WAS FOUND TO HAVE REACHED END OF LIFE. IT WAS SUSPECTED THAT THE SENSOR DATA ACCELERATED THE BATTERY DEPLETION. TECHNICAL SERVICES WAS CONTACTED AND DISCUSSED THAT PROGRAMMING CHANGES CAN CHANGE THE LONGEVITY AND THE DEVICE LIKELY REACHED ERT AFTER THE FOLLOW-UP WITH THE PROGRAMMING CHANGE. TWO WEEKS LATER, THE DEVICE WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CLONMEL IRELAND 1298

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| L| R 1298| 4457| 4470