BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2050249 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03743
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    January 3, 2011
    Report Date
    February 17, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LABORATORY ANALYSIS DETERMINED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION, BUT REACHED ERT EARLIER THAN PREVIOUSLY 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 AMBULATORY (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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE DEVICE HAD DISPLAYED ONE YEAR REMAINING FOR APPROXIMATELY A YEAR. THE CURRENT INTERROGATION SHOWED LESS THAN HALF A YEAR BATTERY LIFE REMAINING. IT WAS NOTED THAT THE OUTPUT WAS PROGRAMMED HIGHER IN THE ATIRUM DUE TO INCREASED THRESHOLD MEASUREMENTS FOR THE RIGHT ATRIAL (RA) LEAD. THE PATIENT IS PACED 100 PERCENT IN BOTH CHAMBERS AND IS PACEMAKER DEPENDENT. THE DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION. 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 1297

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR 4472| 1297| (B)(4)| 1280