BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3211086 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07605
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 26, 2013
    Report Date
    June 7, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Removal / Correction Number
    Z-0026-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BOSTON SCIENTIFIC HAS ISSUED AN ADVISORY COMMUNICATION REGARDING AN OLDER SUBSET OF COGNIS/TELIGEN DEVICES THAT IS MORE SUSCEPTIBLE TO THIS ANOMALY. SPECIFICALLY, THE PERFORMANCE OF A LOW VOLTAGE CAPACITOR MAY BE COMPROMISED OVER TIME, CAUSING AN INCREASED CURRENT DRAIN THAT CAN LEAD TO PREMATURE BATTERY DEPLETION. THIS PARTICULAR DEVICE WAS INCLUDED IN THE ADVISORY POPULATION.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE DEVICE REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    APPROXIMATELY ONE MONTH LATER, THE DEVICE WAS EXPLANTED AND REPLACED. THE DEVICE HAS SINCE BEEN RETURNED AND IS CURRENTLY IN ANALYSIS. UPON COMPLETION FROM ANALYSIS, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. THE FAULT CODE WAS CONFIRMED TO HAVE BEEN RECORDED ON (B)(6) 2013. EXTERNAL VISUAL INSPECTION OF THE DEVICE NOTED NO ANOMALIES. A SERIES OF AUTOMATED ELECTRICAL/FUNCTIONAL TESTS WERE CONDUCTED AND NO ISSUES WITH DEVICE PERFORMANCE WERE OBSERVED; BASIC SENSING, PACING AND SHOCKING FUNCTIONS OF THE DEVICE WERE VERIFIED. AFTER THE TITANIUM CASE WAS OPENED, MICROSCOPIC VISUAL INSPECTION DID NOT REVEAL ANY IRREGULARITIES. THE BATTERY VOLTAGE WAS LOWER THAN EXPECTED (2.947 VOLTS), BUT STILL SUPPORTED FULL DEVICE FUNCTION. THE BATTERY WAS THEN REMOVED, SO THAT AN EXTERNAL POWER SUPPLY COULD BE CONNECTED TO THE DEVICE FOR FURTHER ANALYSIS. A HIGHER THAN NORMAL CURRENT USAGE WAS OBSERVED. ELECTRICAL TESTING ISOLATED THE HIGH CURRENT CONDITION TO TWO LOW-VOLTAGE (BYPASS) CAPACITORS CONNECTED TO THE DEVICE¿S BATTERY. THIS RESULTED IN A HIGH CURRENT DRAIN, WHICH WAS DEPLETING THIS DEVICE¿S BATTERY FASTER THAN NORMAL.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM A CLINICIAN FOLLOWING A REVIEW OF REMOTE HOME MONITORING DATA IN WHICH AN ALERT WAS ISSUED FOR A LOW VOLTAGE FAULT. A DEVICE INTERROGATION WAS THEN PERFORMED AND THE DATA WAS REVIEWED BY BOSTON SCIENTIFIC TECHNICAL SERVICES (TS). UPON REVIEW, THE LOW VOLTAGE FAULT WAS CONFIRMED. NO OTHER FAULTS OR RESETS WERE STORED WITHIN THE DEVICE MEMORY. THE BATTERY VOLTAGE WAS AT 3.020 VOLTS, THEREFORE THERAPY WAS NOT AFFECTED. SINCE THE DEVICE HARDWARE WAS NOT DETECTING THE LOSS OF BATTERY ENERGY, THE BATTERY INDICATORS WERE NOT REFLECTING THE DEPLETION CONDITION AND WERE INACCURATE; CAUSING THE FAULT. TS PERFORMED A LONGEVITY ASSESSMENT AND BASED ON THE BATTERY VOLTAGE MEASUREMENT DATA OVER THE LAST MONTHS, ESTIMATE THE DEVICE COULD MAINTAIN NORMAL THERAPY FUNCTIONS FOR 28 DAYS. AT THIS TIME, THE DEVICE REMAINS IN SERVICE.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309778 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR 0185| E110| 4136