BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 4882809 · Received July 1, 2015

    Report

    Report Number
    2124215-2015-07335
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    April 27, 2015
    Report Date
    June 11, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0088-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF THE DEVICE IS RETURNED, ANALYSIS WILL BE PERFORMED AND THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY. REVIEW OF THE DEVICE MEMORY INDICATED THAT A LOW VOLTAGE ALERT, CODE 1003, WAS RECORDED. THE BATTERY VOLTAGE WAS LOWER THAN EXPECTED. THE TITANIUM CASE WAS OPENED AND THE BATTERY WAS REMOVED SO THAT AN EXTERNAL POWER SUPPLY COULD BE CONNECTED TO THE DEVICE FOR FURTHER ANALYSIS. A HIGHER THAN NORMAL CURRENT DRAIN WAS OBSERVED. ELECTRICAL TESTING ISOLATED THE HIGH CURRENT CONDITION TO A LOW VOLTAGE CAPACITOR CONNECTED TO THE DEVICE'S BATTERY. LOW VOLTAGE 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY, FOLLOWED CLOSELY BY A CODE 1007, INDICATIVE OF A CAPACITOR CHARGE TIME EXCEEDING THE LIMIT. ADDITIONAL INFORMATION RECEIVED INDICATES THAT DEVICE COULD NOT BE INTERROGATED AND WOULD NOT ELICIT A MAGNET RESPONSE. ADDITIONALLY, TELEMETRY COULD NOT BE ESTABLISHED. THIS DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. BOSTON SCIENTIFIC HAS ISSUED AN ADVISORY COMMUNICATION REGARDING AN OLDER SUBSET OF COGNIS/TELIGEN DEVICES THAT IS MORE SUSCEPTIBLE TO A PRODUCT PERFORMANCE 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.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427645 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R 4135| 6937| 1688TC| E110| 0180