BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3212455 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08702
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 16, 2013
    Report Date
    October 8, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z-0087-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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

    FOLLOWING CONFIRMATION OF PRODUCT EXPLANT, THIS EVENT WILL BE FURTHER UPDATED.

    Additional Manufacturer Narrative · 1

    SUBSEQUENTLY, THE DEVICE WAS EXPLANTED AND IS INTENDED TO BE RETURNED FOR A POST MARKET ANALYSIS. ANOTHER BOSTON SCIENTIFIC DEVICE WAS SUCCESSFULLY IMPLANTED IN THE ABSENCE OF ANY ADVERSE PATIENT EFFECTS.

    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. 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, 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. LOW-VOLTAGE (BYPASS) CAPACITORS ARE USED IN THE DEVICE¿S HIGH-VOLTAGE CHARGING OPERATION IN ORDER TO FACILITATE FAST CHARGE TIMES. MALFUNCTION OF THESE CAPACITORS RESULTED IN A HIGH CURRENT DRAIN, WHICH WAS DEPLETING THIS DEVICE¿S BATTERY FASTER THAN NORMAL.

    Additional Manufacturer Narrative · 1

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    Description of Event or Problem · 1

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    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE SOUGHT MEDICAL CARE DUE TO AUDIBLE BEEPING TONES. INTERROGATION OF THE SYSTEM CONFIRMED A FAULT CODE INDICATIVE OF AN INTERNAL BATTERY ANOMALY. THE PROJECTED REMAINING CAPACITY IS UNABLE TO BE SUPPORTED BY THE OBSERVED SYSTEM VOLTAGE AND THE PRODUCT SHOULD BE EXPLANTED TO ENSURE NO COMPROMISES WITH CRITICAL THERAPY. TO DATE, THE PRODUCT REMAINS IMPLANTED AND IN SERVICE WITH NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311901 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P107

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R