BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3212641 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10561
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 13, 2013
    Report Date
    October 8, 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

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

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. A FAULT CODE 1003 WAS CONFIRMED TO HAVE BEEN RECORDED ON (B)(6) 2013. EXTERNAL VISUAL INSPECTION OF THE DEVICE NOTED NO ANOMALIES. A SERIES OF AUTOMATED ELECTRICAL/FUNCTIONAL TESTS WERE CONDUCTED AND NO ISSUES WITH DEVICE PERFORMANCE WERE OBSERVED; BASIC SENSING, PACING AND SHOCKING FUNCTIONS OF THE DEVICE WERE VERIFIED. AFTER THE DEVICE CASE WAS OPENED, MICROSCOPIC VISUAL INSPECTION DID NOT REVEAL ANY IRREGULARITIES. THE BATTERY VOLTAGE WAS LOWER THAN EXPECTED (2.949 VOLTS), BUT STILL SUPPORTED FULL DEVICE FUNCTION. 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 LOW-VOLTAGE CAPACITORS CONNECTED TO THE DEVICE¿S BATTERY. LOW-VOLTAGE CAPACITORS ARE USED IN THE DEVICE¿S HIGH-VOLTAGE CHARGING OPERATION IN ORDER TO FACILITATE FAST CHARGE TIMES. MALFUNCTION OF THESE CAPACITORS RESULTED IN A HIGH CURRENT DRAIN, WHICH WAS DEPLETING THIS DEVICE¿S BATTERY FASTER THAN NORMAL.

    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 UPON INTERROGATION OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) A FAULT CODE 1003 - VOLTAGE TOO LOW FOR PROJECTED REMAINING CAPACITY WAS OBSERVED. THE HEALTH CARE PROFESSIONAL (HCP) CONSULTED WITH BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AND IT WAS DISCUSSED THIS WAS AN EARLY WARNING OF PREMATURE BATTERY DEPLETION, DESPITE THE DEVICE INDICATING 9.5 YEARS REMAINING. A SAVE TO DISK WAS DONE AND EVALUATED BY A BOSTON SCIENTIFIC ENGINEER. PRESENTLY THERAPY WAS UNAFFECTED, AS THERE WAS RESERVE CAPACITY, HOWEVER, THERE WAS A HIGHER CURRENT DRAIN THAN EXPECTED. IT WAS RECOMMENDED THE DEVICE BE CHANGED OUT. BASED ON THE DATA, THERE WAS RESERVE TO MAINTAIN NORMAL THERAPY AND FUNCTION FOR TWENTY-EIGHT DAYS. SUBSEQUENTLY, SURGICAL INTERVENTION WAS PERFORMED AND THE DEVICE WAS SUCCESSFULLY REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312791 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R E102| 0185