BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3210837 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07500
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 21, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Removal / Correction Number
    Z-0026-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

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    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY. FAULT CODE 1003 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 (2.972 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. MALFUNCTION OF THESE CAPACITORS RESULTED IN A HIGH CURRENT DRAIN, WHICH WAS DEPLETING THE BATTERY FASTER THAN NORMAL.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REPORTED HEARING BEEPING COMING FROM THE DEVICE. THE PATIENT WAS BROUGHT INTO THE CLINIC FOR DEVICE EVALUATION. UPON INTERROGATION YELLOW ERROR SCREEN DISPLAYED 'VOLTAGE TOO LOW FOR REMAINING CAPACITY, FC 1003' MESSAGE. THE HEALTH CARE PROFESSIONAL (HCP) CALLED INTO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AND A DISC ANALYSIS WAS PERFORMED. FOLLOWING THE REVIEW OF DISC ANALYSIS IT WAS DETERMINED THE DEVICE WOULD BE CHANGED OUT DUE TO THE CONFIRMATION OF THE FAULT CODE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. A REQUEST FOR DEVICE STATUS HAS BEEN SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE HAS BEEN EXPLANTED AND WILL BE RETURNED FOR ANALYSIS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311671 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR 0148| E102| 1860