BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2052793 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03673
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 25, 2011
    Report Date
    March 28, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    LABORATORY ANALYSIS DETERMINED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION, BUT DECLARED END OF LIFE (EOL) EARLIER THAN PREVIOUSLY ESTIMATED. DECLARATION OF THIS 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 LAST 30 DAYS AVERAGE PACING PERCENTAGE. 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 ELECTIVE REPLACEMENT TIME (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.

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THIS DEVICE SHOULD BE RETURNED TO OUR COMPANY, IT WILL BE ANALYZED AND THIS INVESTIGATION WILL BE REOPENED AND UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE BATTERY ONE YEAR AGO STATED BEGINNING OF LIFE (BOL) AND NOW IS SHOWING END OF LIFE (EOL) INDICATING THAT THE BATTERY MAY BE DEPLETING PREMATURELY. THIS DEVICE IS PART OF MICROCRYSTAL FAILURE MODE 2 ADVISORY, HOWEVER NO ADVISORY INDICATIONS WERE PRESENT. THE DEVICE WAS EXPLANTED AND REPLACED.

    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 75 YR S606| 4087| 1290| MISMATCH| 1388TC| 1388T| 4469