BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3040625 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00620
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 31, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Removal / Correction Number
    Z-0026-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE REMAINS IN-SERVICE. THE INVESTIGATION OF THIS EVENT IS CURRENTLY ON-GOING AS A REQUEST HAS BEEN MADE TO THE LOCAL REPRESENTATIVE FOR ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. REVIEW OF THE DEVICE MEMORY CONFIRMED THAT 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 A COMPROMISED LOW VOLTAGE CAPACITOR THAT IS 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

    THE DEVICE IS CURRENTLY UNDERGOING LABORATORY TESTING TO DETERMINE ROOT CAUSE.

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LOCAL REPRESENTATIVE CONTACTED BOSTON SCIENTIFIC'S TECHNICAL SERVICES (TS) TO REPORT THAT A FAULT CODE# 1003 WAS DISPLAYED UPON INTERROGATION. THE PATIENT HAD REPORTED BEEPING TONES AND WAS SEEN AT THE CLINIC FOR DEVICE FOLLOW-UP. TS DISCUSSED THE ISSUE AND RECOMMENDED THAT THE DEVICE BE EXPLANTED AND REPLACED. TS SUGGESTED THAT A SAVE-TO-DISK AND A MEMORY UPLOAD COULD BE PERFORMED TO BETTER ASSESS THE DEVICE'S CURRENT CONDITION. A MEMORY UPLOAD WAS PERFORMED AND WAS SENT TO BOSTON SCIENTIFIC FOR ANALYSIS. THE MEMORY UPLOAD WAS REVIEWED WHICH CONFIRMED THAT A LOW VOLTAGE FAULT WAS DECLARED DUE TO THREE DAILY VOLTAGES THAT WERE BELOW THE THRESHOLD OF 3.025 VOLTS. THE VOLTAGE IS CURRENTLY AT 3.022 VOLTS AND THERAPY DELIVERY IS UNAFFECTED. USING THE LAST YEARS' WORTH OF DAILY BATTERY VOLTAGE MEASUREMENT DATA, THE ESTIMATED TRUE DEPTH OF BATTERY DISCHARGE TO OBTAIN AN ESTIMATE OF THE FAULT CURRENT WAS PLOTTED. THE CURRENT APPEARS STEADY WITH AN ADDITIONAL CURRENT DRAIN OF MORE THAN 50UA OVER THE EXPECTED NOMINAL VALUE OF 11UA. TO DATE, THE BEHAVIOR APPEARS CONSISTENT OVER TIME; HOWEVER, THIS MAY CHANGE UNPREDICTABLY. AT THIS POINT, THE BATTERY DOES HAVE A SIGNIFICANT RESERVE CAPACITY. THE DATA INDICATES THAT THERE IS SUFFICIENT RESERVE FOR THE DEVICE MAINTAIN NORMAL THERAPY FUNCTIONS FOR TWO WEEKS' TIME.

    Description of Event or Problem · 1

    SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED AND REPLACED. THE DEVICE WAS RECEIVED AT BOSTON SCIENTIFIC'S RETURN PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142567 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR 4017| A155| 4457| 1831| E110| 0155