BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2170933 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-11310
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 7, 2011
    Report Date
    July 26, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LABORATORY ANALYSIS DETERMINED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION, BUT DECLARED 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 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

    TO DATE, THE DEVICE REMAINS IMPLANTED AND HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC. UPON RECEIPT, THE DEVICE WILL UNDERGO DETAILED LABORATORY ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER REVEALED A BATTERY STATUS OF 3 YEARS REMAINING AT THE LAST FOLLOW UP VISIT ON (B)(6), 2010. AFTER ALMOST ONE YEAR, THE BATTERY STATUS HAD MOVED TO ELECTIVE REPLACEMENT TIME. PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE DEVICE WAS REMOVED, REPLACED, AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS 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 Other| R