BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 1951001 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23497
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    October 6, 2010
    Report Date
    November 21, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    MEMORY ANALYSIS SHOWED THAT THE LAST BATTERY CHARGE TIME READING PLACES THE BATTERY STATUS INDICATOR AT 40 PERCENT. PREVIOUSLY IT WOULD HAVE BEEN JUST ABOVE THE 50 PERCENT MARK AND SINCE THE DEVICE ROUNDS UP IT INDICATED 75 PERCENT BATTERY LIFE REMAINING. ALTHOUGH THIS MAY APPEAR TO BE LOWER THAN EXPECTED, THE PARAMETERS WERE RECENTLY CHANGED WHICH MAY CHANGE 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. ANOTHER FACTOR IS THAT THE DEVICE IS PACED 100 PERCENT IN THE VENTRICLE AT AN AVERAGE RATE OF 80 BPM. THIS FASTER PACING RATE CONSUMES MORE BATTERY LIFE AND MAY HAVE CONTRIBUTED TO THE LOWER BATTERY STATUS INDICATOR.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AT THE CURRENT PACEMAKER CHECK THE DEVICE BATTERY SHOWS LESS THAN TWO AND A HALF YEARS LONGEVITY, HOWEVER LESS THAN A YEAR AGO THE DEVICE STATED THAT IT HAD GREATER THAN FIVE YEARS BATTERY LIFE REMAINING. THE AUTOCAPTURE FEATURE ON THE DEVICE WAS TURNED OFF AND A MEMORY ANALYSIS WAS SENT INTO TECHNICAL SERVICES FOR REVIEW. THE DEVICE REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR (B)(4)| (B)(4)| (B)(4)| MISMATCH| (B)(4)