BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3040717 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00839
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 5, 2013
    Report Date
    January 24, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 ON (B)(6) 2013. ALTHOUGH THE DEVICE MEMORY DIAGNOSTICS DEMONSTRATED THAT THE DAILY BATTERY VOLTAGE MEASUREMENTS DISPLAYED AN IRREGULAR PATTERN OF DISCHARGE, THE BATTERY VOLTAGE LEVEL AT EXPLANT 2.987 VOLTS 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

    UPON RECEIPT, THE DEVICE WILL UNDERGO DETAILED ANALYSIS TO DETERMINE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE REMAINS IN-SERVICE. THE PATIENT HAS BEEN SCHEDULED FOR DEVICE REPLACEMENT IN THE NEAR FUTURE.

    Description of Event or Problem · 1

    SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED AND REPLACED WITHOUT INCIDENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CLINIC NURSE HAD CONTACTED THE LOCAL REPRESENTATIVE TO REPORT THAT THIS PATIENT'S MONITORING SYSTEM DETECTED A YELLOW ALERT ASSOCIATED WITH A "VOLTAGE TOO LOW FOR PROJECTED REMAINING CAPACITY". THE LOCAL REPRESENTATIVE CONTACTED BOSTON SCIENTIFIC'S TECHNICAL SERVICES (TS) TO DISCUSS THE ISSUE AND RECOMMENDED THAT THE DEVICE SHOULD BE EXPLANTED. IN-HOUSE ENGINEERING REVIEWED STORED DATA FROM THE PATIENT'S MONITORING SYSTEM. THE DEVICE VOLTAGE BEGAN DECREASING MUCH MORE RAPIDLY THAN EXPECTED (B)(6) 2012. USING THE LAST YEARS' WORTH OF DAILY BATTERY VOLTAGE MEASUREMENT DATA, THE ESTIMATED TRUE DEPTH OF BATTERY DISCHARGE TO OBTAIN AN ESTIMATE OF THE FAULT CURRENT WAS PLOTTED. THE CURRENT APPEARS INTERMITTENT/IRREGULAR WITH AN AVERAGE ADDITIONAL CURRENT DRAIN OF 200UA OVER THE EXPECTED NOMINAL VALUE OF 12UA. TO DATE, THE BEHAVIOR APPEARS INCONSISTENT OVER TIME AND THE FAILURE MODE MAY CHANGE UNPREDICTABLY. AT THIS POINT, THE BATTERY DOES HAVE A SIGNIFICANT RESERVE CAPACITY. THE DATA INDICATES THERE IS SUFFICIENT RESERVE FOR THE DEVICE MAINTAIN NORMAL THERAPY FUNCTIONS FOR 1 WEEK'S TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142930 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR E110| 0185| 4136