BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3211337 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08108
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 7, 2013
    Report Date
    June 10, 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

    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 [A/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

    (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

    AS OF THIS DATE, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. WHEN THE DEVICE HAS BEEN EXPLANTED AND RETURNED, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE REPORTED BEEPING TONES FROM THEIR DEVICE WHEN IN CLOSE PROXIMITY TO THEIR MICROWAVE. IT WAS SUSPECTED THE TONES WERE DUE TO ELECTIVE REPLACEMENT INDICATOR (ERI) BATTERY STATUS. IT WAS RECOMMENDED A FOLLOW UP VISIT BE SCHEDULED. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED REGARDING WHETHER THIS COULD BE RELATED TO THE MICROWAVE AND INDICATED NO RESTRICTIONS USING A MICROWAVE IF USED AS INSTRUCTED. A FOLLOW UP VISIT WAS PERFORMED. IT WAS DETERMINED THIS DEVICE WAS BEEPING. A MEMORY DOWNLOAD WAS PERFORMED. ANALYSIS DETERMINED THE DEVICE HARDWARE IS NOT DETECTING THE LOSS OF BATTERY ENERGY AND THE BATTERY STATUS INDICATORS ARE INACCURATE. THERE WAS CONCERN THE DEVICE IS MALFUNCTIONING. DEVICE REPLACEMENT WITHIN THE NEXT FOUR WEEKS WAS RECOMMENDED. AS OF THIS DATE, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AFTER THE PHYSICIAN WAS INFORMED THERAPY MAY BE COMPROMISED, A DECISION WAS MADE TO REPLACE THIS DEVICE WITHIN THE NEXT WEEK. UPON REMOVAL, RETURN OF PRODUCT IS INTENDED.

    Description of Event or Problem · 1

    SUBSEQUENTLY, A REPLACEMENT PROCEDURE WAS PERFORMED. THIS DEVICE WAS REMOVED, REPLACED AND RETURNED FOR ANALYSIS. POST PROCEDURE, ACCEPTABLE MEASUREMENTS WERE OBTAINED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309423 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1