BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2780557 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13005
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 18, 2012
    Report Date
    October 18, 2012
    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

    UPON EXPLANT, THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    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 A LOW VOLTAGE BATTERY FAULT (FAULT CODE 1003) HAD BEEN RECORDED. EXTERNAL VISUAL INSPECTION OF THE DEVICE NOTED NO ANOMALIES. THE DEVICE HAD NORMAL PACING, SENSING AND DEFIBRILLATOR FUNCTIONS WHILE IMPLANTED. 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. FURTHER 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

    THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND REPLACED APPROXIMATELY ONE WEEK LATER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS IN THE CLINIC FOR A NORMAL DEVICE CHECK. UPON INTERROGATION OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), A FAULT CODE DISPLAYED INDICATING THE BATTERY VOLTAGE WAS TOO LOW FOR THE PROJECTED REMAINING CAPACITY, HOWEVER THE BATTERY STATUS WAS SHOWING 9.5 YEARS REMAINING. THE PATIENT WAS LAST SEEN IN (B)(6) 2012 AND EVERYTHING WAS NORMAL AT THAT TIME. THE DEVICE MEMORY WAS DOWNLOADED AND SENT TO BOSTON SCIENTIFIC ENGINEERING FOR REVIEW. THE DEVICE DECLARED THE LOW VOLTAGE FAULT ON (B)(6) 2012. BASED ON THE CURRENT VOLTAGE VALUE (3.000V), THE DEVICE THERAPY IS NOT AFFECTED. A LONGEVITY CALCULATION PERFORMED CONFIRMED THE DEVICE IS ALIGNED WITH NOMINAL VALUES AND THE DEVICE HARDWARE IS NOT DETECTING THE LOSS OF BATTERY ENERGY. BECAUSE OF THIS, THE BATTERY STATUS INDICATORS ARE NOT REFLECTING THE DEPLETION CONDITION AND ARE INACCURATE. SINCE THE DEVICE IS NOT FUNCTIONING APPROPRIATELY, REPLACEMENT IS RECOMMENDED. ENGINEERS CONCLUDED THAT THE CURRENT APPEARS STEADY AND CONSISTENT, HOWEVER NOTES THIS COULD CHANGE UNPREDICTABLY AND THERAPY COULD BE COMPROMISED. THE FIELD REPRESENTATIVE INDICATED THE PATIENT IS SCHEDULED FOR A DEVICE REPLACEMENT WITHIN THE NEXT WEEK AND ONCE THE DEVICE IS REPLACED, IT WILL BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    --

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR 4135| 0184| E110