BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1954106 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24269
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 16, 2010
    Report Date
    February 9, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING COMPLETION OF LABORATORY ANALYSIS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    LABORATORY ANALYSIS DETERMINED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION, BUT ERT, EARLIER THAN PREVIOUSLY ESTIMATED DUE TO A CHANGE IN BATTERY CURRENT CONSUMPTION. IN SOME CIRCUMSTANCES, THIS CHANGE MAY ALSO CAUSE A REVISION OF THE POINT IN BATTERY LIFE AT WHICH THE DEVICE WILL DECLARE ERT IN ORDER TO ENSURE 3 MONTHS OF BATTERY LIFE BETWEEN ERT AND EOL. THIS ERT DECLARATION POINT AND ASSOCIATED ESTIMATE OF TIME TO ERT DEPEND ON DEVICE OPERATING CURRENT AND BATTERY DEPLETION TO DATE. FACTORS INFLUENCING OPERATING CURRENT INCLUDE PACING RATE, AMPLITUDE, PULSE-WIDTH, LEAD IMPEDANCE, AND THE LAST 30 DAYS AVERAGE PACING PERCENTAGE. DEVICE REPROGRAMMING AFFECTING PACING DEMAND, TEMPORARY AMBULATORY SUSPENSION OF THE RV PACE AUTO CAPTURE FEATURE, AND GRADUAL CHANGES IN LEAD IMPEDANCE ARE SOME FACTORS AFFECTING OPERATING CURRENT WHICH MAY CAUSE A REVISION TO THE ERT DECLARATION POINT. 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 THIS DEVICE EXHIBITED ERT BATTERY STATUS, FOLLOWING AN IMPLANT DURATION OF 4.9 YEARS. THE DEVICE IS INTENDED TO BE RETURNED FOR A POST MARKET EVALUATION, AS THE PHYSICIAN INDICATED AN ACCELERATED RATE OF DECLINE PER PRODUCT LABELING. NO SPECIFIC ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    THE PRODUCT WAS EXPLANTED AND RETURNED FOR A POST MARKET ASSESSMENT.

    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 Required Intervention