BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2151667 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-11120
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    April 2, 2011
    Report Date
    April 4, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS PACEMAKER WAS SUCCESSFULLY INTERROGATED; TELEMETRY OPERATIONS WERE CONFIRMED TO BE NORMAL. REVIEW OF DEVICE DATA FOUND THAT NO HARDWARE RESETS HAD BEEN RECORDED BY THE DEVICE. THE BATTERY STATUS-PROGRAMMING WAS ERT-VVI. WHEN TESTED AT THIS SETTING, THE PACEMAKER PACED AND SENSED APPROPRIATELY AND EXHIBITED A MAGNET RATE OF 85 BPM. WHEN PROGRAMMED TO ERT-DDD, THE DEVICE AGAIN PACED AND SENSE NORMALLY WITH A MAGNET RATE OF 85 BPM. FORCED LEAD IMPEDANCE TESTS RESULTED IN NORMAL MEASUREMENTS. PACING OUTPUTS WERE VERIFIED TO BE NORMAL. PRINTOUTS RECEIVED WITH THE DEVICE WERE REVIEWED AND IT WAS NOTED THAT THE PACEMAKER DECLARED ERT ON (B)(6) 2011. THE PRINTOUTS ALSO INDICATED THE PACEMAKER HAD RECORDED 25,371 ARRHYTHMIAS IN THE ARRHYTHMIA LOGBOOK. DESPITE DETAILED ANALYSIS OF THIS DEVICE BEHAVIOR, THE ROOT CAUSE OF THE ISSUE COULD NOT BE DEFINITIVELY DETERMINED. DECLARATION OF THE ERT INDICATOR OCCURS AFTER THE DEVICE COMPLETES AN INTERNAL CALCULATION OF BATTERY CONSUMPTION. FACTORS INFLUENCING THIS CALCULATION INCLUDE PACING RATE, AMPLITUDE, PULSE-WIDTH, LEAD IMPEDANCE, AND THE AVERAGE PACING PERCENTAGE OVER THE LAST 30 DAYS. ANY CHANGES IN THOSE FACTORS WILL IMPACT THE BATTERY CONSUMPTION CALCULATION. 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 DURING A ROUTINE FOLLOW-UP VISIT, THIS PACEMAKER HAD A MAGNET RATE OF 90 BPM, WHICH INDICATES A BATTERY STATUS OF GOOD-ELECTIVE REPLACEMENT NEAR (ERN), WITH INTENSIFIED PATIENT FOLLOW UP RECOMMENDED. A REPLACEMENT PROCEDURE WAS SCHEDULED FOR APPROXIMATELY TWO MONTHS LATER. JUST PRIOR TO DEVICE REPLACEMENT, IT WAS NOTED THAT THE BATTERY STATUS WAS BEGINNING OF LIFE (BOL), WITH THE BATTERY GAUGE INDICATOR FULL. THE DEVICE WAS RE-INTERROGATED AND WAS NOTED TO BE AT BOL WITH TWO YEARS LONGEVITY REMAINING (WITHOUT REPROGRAMMING NOMINAL SETTINGS). A MAGNET WAS THEN PLACED ON THE DEVICE AND, DESPITE THE BATTERY STATUS OF BOL AND THE BATTERY GAUGE INDICATOR LEVEL APPEARING FULL; THE MAGNET RATE WAS 85 BPM, INDICATING A BATTERY STATUS OF ELECTIVE REPLACEMENT TIME (ERT). PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE DEVICE WAS THEN EXPLANTED, REPLACED, AND RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R