BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1944776 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-23226
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    November 7, 2010
    Report Date
    April 18, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Removal / Correction Number
    Z-0187-06 TO Z-0190-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    LABORATORY ANALYSIS DETERMINED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION, BUT DECLARED ELECTIVE REPLACEMENT TIME (ERT) 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 ERT DECLARATION POINT TO ENSURE A MINIMUM OF 3 MONTHS BATTERY LIFE BETWEEN ERT AND END OF LIFE. 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

    THE PACEMAKER REMAINS IMPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS PACEMAKER WAS HOSPITALIZED FOR SHORTNESS OF BREATH AND FATIGUE. THE PATIENT WAS FOUND TO BE IN ATRIAL FIBRILLATION. UPON TESTING THIS PACEMAKER THE BATTERY GAUGE DISPLAYED BEGINNING OF LIFE (BOL) HOWEVER THE ESTIMATED LONGEVITY DISPLAYED LESS THAN .5 YEARS REMAINING. ALL OTHER DEVICE TESTING WAS NORMAL. UPON FURTHER TESTING THE DEVICE THEN DECLARED ELECTIVE REPLACEMENT TIME (ERT). A DEVICE MEMORY DOWNLOAD WAS PERFORMED AND THE REASON THE DEVICE HAD INCORRECTLY INDICATED BOL OR WHY THE DEVICE HAD NOT DISPLAYED ERT SOONER COULD NOT BE DETERMINED. THE DEVICE HAD REACHED ERT THEREFORE DEVICE EXPLANT WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    THE DEVICE WAS EXPLANTED THREE MONTHS LATER AND RETURNED 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 81 YR (B)(4)| (B)(4)| (B)(4)| 1298