BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3041094 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00921
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 25, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Removal / Correction Number
    Z-0026-2014
    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 THAT 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

    TO DATE, THE DEVICE REMAINS IN-SERVICE. THE PATIENT HAS BEEN SCHEDULED FOR DEVICE REPLACEMENT IN THE VERY NEAR FUTURE. UPON RECEIPT, THE DEVICE WILL UNDERGO DETAILED ANALYSIS TO DETERMINE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CLINIC NURSE CONTACTED BOSTON SCIENTIFIC'S TECHNICAL SERVICES (TS) TO REPORT THAT THIS PATIENT'S MONITORING SYSTEM DETECTED A YELLOW ALERT (VOLTAGE TOO LOW FOR PROJECTED REMAINING CAPACITY). TS DISCUSSED THE ISSUE AND RECOMMENDED REPLACEMENT OF THE DEVICE. SUBSEQUENTLY, A FAMILY MEMBER OF THE PATIENT CONTACTED THE WARRANTY DEPARTMENT TO DISCUSS WARRANTY CREDIT AND UNREIMBURSED MEDICAL EXPENSES. SUBSEQUENTLY, STORED DATA FROM THE PATIENT'S MONITORING SYSTEM WAS REVIEWED BY BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE ENGINEERING. A REVIEW OF STORED DATA CONFIRM THAT THE DEVICE IS DEPLETING AT A MORE RAPID RATE THAN THE INTERNAL COULOMB METER IS MEASURING AND THAT THE LOW VOLTAGE FAULT IS VALID. THE ABNORMAL DEPLETION STARTED SOMETIME BEFORE (B)(6) 2012. USING THE LAST 2 WEEKS' 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 REGULAR WITH AN AVERAGE ADDITIONAL CURRENT DRAIN OF APPROXIMATELY 100UA OVER THE EXPECTED NOMINAL VALUE OF 11UA. THE LAST CALCULATION AGAINST THE VOLTAGE MEASUREMENTS TAKEN AGAINST CAPFORMS BACK TO (B)(6) 2012 WAS CHECKED. THE CURRENT APPEARS TO BE CONSISTENT OVER THAT PERIOD. TO DATE, THE DEVICE HAS BEEN DEPLETING IN A REGULAR FASHION; HOWEVER THE ROOT CAUSE IS UNKNOWN AND THE FAILURE MODE 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 2 WEEKS' TIME.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS RECEIVED AT BOSTON SCIETNIFIC'S RETURN PRODUCTS DEPARTMENT.

    Description of Event or Problem · 1

    --

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143993 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 240 MO 6949| E102| N119| 7120| H170| 4542| MISMATCH| 4076