BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2151723 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-06854
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 12, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SUCCESSFULLY REPLACED AND WILL BE RETURNED FOR LABORATORY ANALYSIS. ONCE ANALYSIS IS COMPLETED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS ANALYZED. DETAILED MECHANICAL AND ELECTRICAL TESTING WAS PERFORMED. THE DEVICE FUNCTIONED NORMALLY THROUGHOUT TESTING. ANALYSIS CONCLUDED THIS DEVICE DID NOT EXPERIENCE A COMPONENT MALFUNCTION OR PREMATURE BATTERY DEPLETION, AND REPLACEMENT INDICATORS WERE DISPLAYED APPROPRIATELY, RELATIVE TO THE ACTUAL BATTERY CONDITION. HOWEVER, SERVICE LIFE FELL SLIGHTLY SHORT OF LONGEVITY EXPECTATIONS AS DEPICTED IN THE INSTRUCTIONS FOR USE THAT WERE ORIGINALLY APPROVED AND DISTRIBUTED WITH THIS DEVICE. LONGEVITY ESTIMATION TOOLS HAVE SINCE BEEN REFINED TO BETTER REFLECT ACTUAL DEVICE PERFORMANCE AND CURRENT CLINICAL PRACTICES. IN ADDITION, ANALYSIS ALSO DETERMINED THAT THIS DEVICE 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE LAST PATIENT FOLLOW UP, THE ESTIMATED BATTERY LONGEVITY WAS MORE THAN TWO YEARS OF LIFE REMAINING. BASED ON THIS INFORMATION, THE NEXT PATIENT FOLLOW UP WAS SCHEDULED FOR SIX MONTHS. WHEN THE DEVICE WAS INTERROGATED AT THIS NEXT SIX MONTH FOLLOW UP, IT WAS DISCOVERED THAT THE DEVICE WAS AT END OF LIFE (EOL) WITH LIMITED THERAPY AVAILABLE. THERE WAS A CONCERN THAT THE BATTERY HAD DEPLETED EARLIER THAN EXPECTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 0982

    Patients

    Seq Age Sex Outcome Treatment
    1