BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2913701 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00041
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 27, 2012
    Report Date
    February 6, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0026-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE ICD REMAINS IMPLANTED AND IN SERVICE. A REPLACEMENT PROCEDURE WILL BE PERFORMED WITHIN TWO WEEKS AND THE EXPLANTED ICD IS EXPECTED TO BE RETURNED FOR LABORATORY ANALYSIS. ONCE ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    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

    SUBSEQUENTLY, THE DEVICE WAS EXPLANTED AND IS INTENDED TO BE RETURNED FOR A POST MARKET EVALUATION. ANOTHER BOSTON SCIENTIFIC DEVICE WAS SUCCESSFULLY IMPLANTED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. REVIEW OF THE DEVICE MEMORY CONFIRMED THREE 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).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HEARD TONES BEING EMITTED FROM THE DEVICE AND WENT TO THE HOSPITAL. INTERROGATION OF THE ICD REVEALED A FAULT CODE AND A WARNING MESSAGE INDICATING THAT THE VOLTAGE WAS TOO LOW FOR THE PROJECTED REMAINING CAPACITY. A MEMORY DOWNLOAD WAS PERFORMED AND SENT TO BOSTON SCIENTIFIC FOR EVALUATION. A COMPANY ENGINEER REVIEWED THE DATA AND CONFIRMED THAT THE DEVICE'S BATTERY IS DEPLETING FASTER THAN EXPECTED. WITH THE CURRENT BATTERY VOLTAGE, THERE IS ENOUGH ENERGY TO MAINTAIN NORMAL FUNCTION AND PROVIDE THERAPY. HOWEVER, DUE TO THE CALCULATED RATE OF ACTUAL BATTERY DEPLETION, THERAPY DELIVERY CAN ONLY BE GUARANTEED FOR TWO WEEKS AND DEVICE REPLACEMENT SHOULD BE CONSIDERED AS SOON AS POSSIBLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20444 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1