BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3040728 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-02524
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    August 11, 2012
    Report Date
    April 5, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0026-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. REVIEW OF THE DEVICE MEMORY CONFIRMED LOW VOLTAGE BATTERY FAULTS (FAULT CODE 1003) HAD BEEN RECORDED. EXTERNAL VISUAL INSPECTION OF THE DEVICE NOTED NO ANOMALIES. INITIAL AUTOMATED TESTING VERIFIED BASIC SENSING, PACING AND SHOCKING FUNCTIONS OF THE DEVICE. AFTER THE TITANIUM CASE WAS OPENED, MICROSCOPIC VISUAL INSPECTION DID NOT REVEAL ANY IRREGULARITIES. 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 COMPROMISED LOW VOLTAGE CAPACITORS THAT ARE CONNECTED TO THE DEVICE¿S BATTERY. THIS TYPE OF COMPONENT MALFUNCTION CAN RESULT IN A HIGH CURRENT DRAIN, WHICH OVER TIME CAN RESULT IN PREMATURE BATTERY DEPLETION, AS WAS OBSERVED IN THIS CASE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT WAS SEEN IN CLINIC DUE TO DEVICE BEEPING FOR TWO WEEKS. UPON INTERROGATION A FAULT CODE 1003 ALERT WAS NOTED (MEASURED BATTERY VOLTAGE IS TOO LOW FOR PROJECTED REMAINING CAPACITY). BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND RECOMMENDED IMMEDIATE REPLACEMENT OF THE DEVICE. THE DEVICE MEMORY WAS SENT IN FOR ENGINEERING ANALYSIS. THE MEMORY CONFIRMED THREE LOW VOLTAGE FAULTS HAD OCCURRED FIVE MONTHS EARLIER AND A HIGHER THAN NORMAL CURRENT DRAIN IN THE DEVICE. NO OTHER FAULTS OR RESETS WERE NOTED AND THERAPY WAS NOT AFFECTED. A REPLACEMENT PERIOD OF ONE WEEK WAS RECOMMENDED. SEVEN DAYS LATER THIS DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED.

    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
    143974 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| L| R