BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2913649 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00076
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 19, 2012
    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 Location
    AZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE MEMORY CONFIRMED THE LOW VOLTAGE FAULT. THE FAULT WAS DECLARED ON (B)(4), 2012 DUE TO THREE DAILY VOLTAGES THAT WERE BELOW THRESHOLD. THERE WERE NO OTHER SUSPECIOUS FAULTS OR RESETS STORED WITHIN THE DEVICE MEMORY. BASED ON THE BATTERY VOLTAGE MEASUREMENT, THERAPY DELIVERY WOULD NOT HAVE BEEN COMPROMISED. HOWEVER, SINCE THE DEVICE HARDWARE IS NOT DETECTING THE LOSS OF BATTERY ENERGY, CAUSING THE INDICATORS TO BE INACCURATE, A REPLACEMENT WAS RECOMMENDED AS SOON AS POSSIBLE.THE DEVICE REMAINS IN SERVICE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    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

    APPROXIMATELY THREE WEEKS LATER, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO THE REPORTED OBSERVATIONS. THE PRODUCT WAS RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    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 BODY FLUID CONTAMINATION IN THE DEFIBRILLATION (POSITIVE) LEAD BARREL AND TERMINAL BLOCK. 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EMITTING BEEP TONES SO THE PATIENT WAS BROUGHT IN TO THE CLINIC FOR A DEVICE CHECK. UPON DEVICE INTERROGATION, A FAULT CODE WAS DISPLAYED INDICATING THE BATTERY VOLTAGE WAS TOO LOW FOR THE PROJECTED REMAINING CAPACITY; HOWEVER THE DEVICE LONGEVITY SHOWED 9.5 YEARS REMAINING. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED AND DISCUSSED THAT THERE WAS A SOURCE OF HIGH CURRENT DRAIN OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21421 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR E102| 0175