BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3212988 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09343
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 10, 2013
    Report Date
    October 8, 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 Occupation
    PHYSICIAN

    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

    AT THIS TIME, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. ONCE ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. REVIEW OF THE DEVICE MEMORY CONFIRMED A LOW VOLTAGE BATTERY FAULT (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

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    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED AN ERROR CODE INDICATING THAT THE BATTERY VOLTAGE WAS TOO LOW FOR THE PROJECTED REMAINING CAPACITY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. A MEMORY DOWNLOAD WAS PERFORMED AND SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR FURTHER EVALUATION. THE DATA WAS REVIEWED BY THE ENGINEERING GROUP AND CONFIRMED THAT THE DEVICE IS EXPERIENCING FASTER BATTERY DEPLETION THAN EXPECTED, AND THE BATTERY STATUS INDICATORS ARE NOT REFLECTING THE DEPLETION CONDITION ACCURATELY. THE DEVICE CURRENTLY HAS SUFFICIENT ENERGY TO MAINTAIN NORMAL FUNCTIONS FOR 28 DAYS BUT THIS COULD CHANGE UNPREDICTABLY. THE TS CONSULTANT DISCUSSED THAT DEVICE REPLACEMENT SHOULD BE STRONGLY CONSIDERED AS SOON AS POSSIBLE. THIS INFORMATION WAS TO BE COMMUNICATED TO THE PHYSICIAN.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312421 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R 0165| F102| 1870