BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2162654 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07295
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 20, 2011
    Report Date
    August 9, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Removal / Correction Number
    Z-0187-06 TO Z-0190-06
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THIS DEVICE HAS BEEN REMOVED AND RETURNED ANALYSIS WILL BE PERFORMED IN AN EFFORT TO DETERMINE THE ROOT CAUSE OF THIS ISSUE.

    Additional Manufacturer Narrative · 1

    WHEN THE DEVICE HAS BEEN RETURNED AND ANALYSIS PERFORMED, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

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

    ADDITIONAL INFORMATION WAS RECEIVED. THIS DEVICE WAS REMOVED, REPLACED AND IS BEING RETURNED FOR ANALYSIS. NO FURTHER PATIENT SYMPTOMS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS PACEMAKER PRESENTED TO THE HOSPITAL WITH COMPLAINTS OF NOT FEELING WELL. INTERROGATION REVEALED THE DEVICE HAD REACHED END OF LIFE (EOL) ONE MONTH AGO. THREE MONTHS EARLIER, INTERROGATION REVEALED ONE YEAR LONGEVITY REMAINING. AN INTERNAL TECHNICAL SERVICES REPRESENTATIVE WAS CONTACTED REGARDING (EOL) DEVICE FUNCTION AT EOL. THERE WAS CONCERN THAT THIS DEVICE REACHED EOL MORE RAPIDLY THAN EXPECTED. AS THE PATIENT IS ONE HUNDRED PERCENT PACING DEPENDENT A REPLACEMENT PROCEDURE IN BEING SCHEDULED AS AN EMERGENT PROCEDURE. NO FURTHER PATIENT SYMPTOMS WERE REPORTED. THIS DEVICE IS INCLUDED IN THE CRYSTAL TIMING COMPONENT FAILURE MODE 1 PRODUCT ADVISORY WAS INITIALLY COMMUNICATED ON (B)(6) 2005. THIS ISSUE MAY BE A SYMPTOM OF THIS ADVISORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1297

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening| R 4087| MISMATCH| 1297| 4088