BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2913348 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00069
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 12, 2012
    Report Date
    January 10, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Removal / Correction Number
    Z-0026-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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

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

    TO DATE, THE DEVICE HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC'S RETURN PRODUCTS DEPARTMENT.

    Description of Event or Problem · 1

    THE DEVICE WAS RECEIVED AT BOSTON SCIENTIFIC'S RETURN PRODUCTS DEPARTMENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT CONTACTED BOSTON SCIENTIFIC'S PATIENT SERVICES (PS) TO REPORT THAT THIS DEVICE WAS GENERATING BEEPING TONES. PATIENT SERVICES RECOMMENDED THAT THE PATIENT SHOULD CONTACT THE PHYSICIAN TO DISCUSS FURTHER. ON THE SAME DAY, THIS HEALTH CARE PROFESSIONAL (HCP) CONTACTED BOSTON SCIENTIFIC'S TECHNICAL SERVICES (TS) TO REPORT THAT THIS DEVICE WAS GENERATING BEEPING TONES AND DISPLAYED A FAULT CODE #1003 UPON INTERROGATION. TS DISCUSSED THE ISSUE AND RECOMMENDED THAT THIS PATIENT SHOULD BE SCHEDULED FOR DEVICE REPLACEMENT. THE HCP INFORMED TS THAT THE PATIENT HAD BEEN SCHEDULED FOR DEVICE REPLACEMENT AND A SAVE-TO-DISK/MEMORY UPLOAD WOULD BE SENT TO BOSTON SCIENTIFIC FOR ANALYSIS. THE HCP WAS PLANNING TO CONTACT THE LOCAL REPRESENTATIVE TO DISCUSS FURTHER. THE DATA DISKS WERE RECEIVED AND SENT TO IN-HOUSE ENGINEERING FOR ANALYSIS. THE DISKS WERE REVIEWED AND A LOW VOLTAGE FAULT WAS CONFIRMED (DETECTED BY THE DEVICE IN (B)(6) 2012 DUE TO THREE DAILY VOLTAGES THAT WERE BELOW THE THRESHOLD OF 3.025 VOLTS. AT THE TIME OF THE MEMORY UPLOAD, THE VOLTAGE WAS 3.022 AND THERAPY DELIVERY WAS UNAFFECTED. USING THE LAST YEAR'S 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 84UA OVER THE EXPECTED NOMINAL VALUE OF 11UA. CURRENTLY, THIS BEHAVIOR APPEARS CONSISTENT OVER TIME BUT MAY CHANGE UNPREDICTABLY. THE DATA INDICATED THAT THERE IS SUFFICIENT RESERVE FOR THE DEVICE TO MAINTAIN NORMAL THERAPY FUNCTIONS FOR 2 WEEKS TIME TO ALLOW FOR SCHEDULING OF DEVICE REPLACEMENT. TWO DAYS LATER, THE PATIENT WAS PRESENTED BACK TO THE ELECTROPHYSIOLOGY (EP) LABORATORY AND THE DEVICE WAS REPLACED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20206 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| L| R E110| 4244| T125| 1831| 0144| 4470