BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1946179 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20113
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    October 14, 2010
    Report Date
    November 10, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Removal / Correction Number
    Z-0187-06 THRU Z-0190-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LABORATORY ANALYSIS DETERMINED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION, BUT REACHED EOL EARLIER THAN ESTIMATED, DUE TO A CHANGE IN BATTERY CURRENT CONSUMPTION. 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 AWAY FROM THE PROGRAMMER, 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. THE DEVICE WAS SUBJECTED TO A LONGEVITY CALCULATION BASED ON SYSTEM GUIDE LABELING FOR THIS MODEL DEVICE AND 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. THE DEVICE LONGEVITY WAS TESTED A SECOND TIME WITH A REVISED LONGEVITY CALCULATOR. THIS DEVICE PASSED THIS SECOND CALCULATION.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE HAS BEEN RETURNED FOR ANALYSIS. UPON COMPLETION OF THE ANALYSIS, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT A REPLACEMENT PROCEDURE WAS PERFORMED. THIS DEVICE WAS REMOVED AND REPLACED SUCCESSFULLY. THERE WAS CONCERN THAT THE BATTERY DEPLETED MORE RAPIDLY THAN EXPECTED. REPORTEDLY, ANNUAL FOLLOW UP VISITS HAD BEEN PERFORMED AND IT WAS NOTED THE LONGEVITY HAD DEPLETED TO END OF LIFE (EOL) SUDDENLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 0882

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention