BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 1952616 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23559
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 17, 2008
    Report Date
    December 7, 2010
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LABORATORY ANALYSIS DETERMINED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION, BUT DUE TO A CHANGE IN BATTERY CURRENT CONSUMPTION. AN INITIAL LONGEVITY CALCULATION BASED ON SYSTEM GUIDE LABELING FOR THIS DEVICE WAS FOUND TO NOT MEET LONGEVITY. DESIGN ENGINEERS HAVE NOTED DEFICIENCIES IN THIS CALCULATION AND DETERMINED THAT IT DOES NOT ACCURATELY REPRESENT THE DEVICE'S BATTERY PERFORMANCE. AS A RESULT, THE DEVICE LONGEVITY WAS TESTED A SECOND TIME, USING A REVISED LONGEVITY CALCULATOR THAT HAS CORRECTED THE DEFICIENCIES OF THE ORIGINAL CALCULATOR. THIS DEVICE PASSED THE SECOND LONGEVITY CALCULATION. IN SOME CIRCUMSTANCES, THIS CHANGE MAY ALSO CAUSE A REVISION OF THE POINT IN BATTERY LIFE AT WHICH THE DEVICE WILL DECLARE ERT IN ORDER TO ENSURE 3 MONTHS OF BATTERY LIFE BETWEEN ERT AND EOL. THIS ERT DECLARATION POINT AND ASSOCIATED ESTIMATE OF TIME TO ERT DEPEND ON DEVICE OPERATING CURRENT AND BATTERY DEPLETION TO DATE. FACTORS INFLUENCING OPERATING CURRENT INCLUDE PACING RATE, AMPLITUDE, PULSE-WIDTH, LEAD IMPEDANCE, AND THE LAST 30 DAYS AVERAGE PACING PERCENTAGE. DEVICE REPROGRAMMING AFFECTING PACING DEMAND, TEMPORARY AMBULATORY SUSPENSION OF THE RV PACE AUTO CAPTURE FEATURE, AND GRADUAL CHANGES IN LEAD IMPEDANCE ARE SOME FACTORS AFFECTING OPERATING CURRENT WHICH MAY CAUSE A REVISION TO THE ERT DECLARATION POINT. THE ESTIMATED LONGEVITY REMAINING AND BATTERY STATUS GAUGE DISPLAYED BY THE PROGRAMMER ARE BASED ON BATTERY CURRENT CONSUMPTION CALCULATIONS AT THE TIME OF INTERROGATION, AND CALCULATIONS PERFORMED INTERNAL TO THE DEVICE ARE SUSPENDED DURING THE SESSION. WHEN AMBULATORY, THE DEVICE PERIODICALLY ASSESSES OPERATING CURRENT AND MAY REVISE THE ERT DECLARATION POINT TO ENSURE A MINIMUM OF 3 MONTHS BATTERY LIFE BETWEEN ERT AND EOL. THIS DEVICE ASSESSMENT OF OPERATING CURRENT, BATTERY CHARGE STATE, AND REVISION OF THE ERT DECLARATION POINT MAY CAUSE DIFFERENCES AND FLUCTUATIONS RELATIVE TO PREVIOUS PROGRAMMER BATTERY STATUS INDICATORS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INITIAL INFORMATION THAT DURING A ROUTINE FOLLOW-UP BATTERY STATUS ANOMALIES RELATED TO LONGEVITY REMAINING WERE OBSERVED. A MEMORY DOWNLOAD WAS LATER PERFORMED AND ANALYZED BY A BOSTON SCIENTIFIC ENGINEER WHICH CONFIRMED NORMAL LONGEVITY BASED UPON PROGRAMMED PARAMETERS. THE DEVICE REMAINED IN SERVICE, WAS SUBSEQUENTLY EXPLANTED ONE YEAR LATER WITHOUT COMPLICATION, AND IS INCLUDED IN THE INSIGNIA MICROCRYSTAL FAILURE MODE 2 ((B)(6) 2005) ADVISORY. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CLONMEL IRELAND 1297

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR 4269| 2022T| 1297