BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2780644 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12582
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 28, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE DEVICE WILL UNDERGO LABORATORY TESTING TO DETERMINE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. EXTERNAL VISUAL INSPECTION OF THE DEVICE REVEALED NO ANOMALIES. REVIEW OF THE DEVICE MEMORY CONFIRMED THAT FAULT CODE 1003 WAS RECORDED. ALTHOUGH THE DEVICE MEMORY DIAGNOSTICS DEMONSTRATED THAT THE DAILY BATTERY VOLTAGE MEASUREMENTS DISPLAYED AN IRREGULAR PATTERN OF DISCHARGE, THE BATTERY VOLTAGE LEVEL AT EXPLANT WAS SUFFICIENT TO ENSURE THERAPY AVAILABILITY/DELIVERY WHILE THE DEVICE WAS IMPLANTED. THE DEVICE CASE WAS THEN OPENED TO FACILITATE ANALYSIS OF THE INTERNAL COMPONENTS. THE BATTERY WAS SEPARATED FROM THE OTHER DEVICE ELECTRONICS AND THE OVERALL CURRENT DRAW OF THE CIRCUITRY WAS MEASURED. A NORMAL CURRENT DRAIN WAS OBSERVED WITHIN THE CIRCUITRY. COLLECTIVELY, THE PATTERN OF IRREGULAR DAILY BATTERY VOLTAGE MEASUREMENTS IN CONJUNCTION WITH NORMAL POWER LEVELS AND DEVICE HYBRID CURRENT DRAW IS CONSISTENT WITH BEHAVIOR OF DEVICES WHERE A LATENT CURRENT LEAKAGE PATH HAS OCCURRED WITHIN THE BATTERY ITSELF, RESULTING IN A PARTIAL DEPLETION OF THE BATTERY.

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION SUGGESTS THAT THIS DEVICE REMAINS IN-SERVICE.

    Description of Event or Problem · 1

    SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO REPORTED ADVERSE EVENTS DURING OR FOLLOWING THE REPLACEMENT PROCEDURE. THE DEVICE IS ENROUTE TO BOSTON SCIENTIFIC'S RETURN PRODUCTS DEPARTMENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LOCAL REPRESENTATIVE CONTACTED BOSTON SCIENTIFIC'S TECHNICAL SERVICES (TS) TO REPORT THAT THIS PATIENT WAS SEEN IN-CLINIC BECAUSE THE DEVICE WAS GENERATING BEEPING TONES. THE DEVICE WAS SUCCESSFULLY INTERROGATED AND A FAULT CODE#1003 (VOLTAGE TOO LOW FOR PROJECTED REMAINING BATTERY CAPACITY) WAS DISPLAYED. TS DISCUSSED THE ISSUE AND RECOMMENDED THAT THE DEVICE SHOULD BE REPLACED IMMEDIATELY. TS ASSISTED THE LOCAL REPRESENTATIVE WITH A SAVE-TO-DISK. TS EXPLAINED THAT ANALYSIS OF A SAVE-TO-DISK MAY HELP TO DETERMINE THE REMAINING LONGEVITY MORE ACCURATELY. A SAVE-TO-DISK WAS PERFORMED AND WAS RECEIVED FOR ANALYSIS. ANALYSIS OF THE STORED DATA VERIFIED THAT A LOW VOLTAGE FAULT WAS DECLARED ON (B)(6) 2012. THIS OCCURRED BECAUSE THREE DAILY VOLTAGE MEASUREMENTS WERE BELOW THE THRESHOLD OF 3.025 VOLTS. THE VOLTAGE HAS CURRENTLY RECOVERED TO 3.061 VOLTS AND THERAPY AVAILABILITY IS UNAFFECTED. THE DAILY BATTERY VOLTAGES REVEALED THAT THE DEVICE BEGAN DEPLETING IRREGULARLY IN LATE (B)(6) 2012. THERE WAS A SIGNIFICANT DROP IN VOLTAGE ON (B)(6) 2012 FOLLOWED BY RECOVERY. THE RECOVERY HAS APPEARED STABLE OVER THE LAST MONTH. AT THIS POINT IN TIME, THE BATTERY DOES HAVE A SIGNIFICANT RESERVE CAPACITY; HOWEVER, THE BEHAVIOR APPEARS INCONSISTENT OVER TIME AND A CALCULATION OF THE RESERVE MARGIN COULD NOT BE DETERMINED WITH A HIGH DEGREE OF ACCURACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR E102| 1852| 0157