BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3212586 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08867
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 16, 2013
    Report Date
    June 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 Location
    OK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED. THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON 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 BODY FLUID CONTAMINATION IN THE LEAD BARRELS. 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 CAPACITOR(S) 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 A VOLTAGE TOO LOW FOR REMAINING CAPACITY FAULT MESSAGE WAS OBSERVED FOR THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). A COPY OF DEVICE MEMORY WAS SUBMITTED TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR ANALYSIS. ANALYSIS OF DEVICE MEMORY REVEALED THAT THE FAULT MESSAGE WAS APPROPRIATE AND NO OTHER SUSPICIOUS FAULTS OR RESETS WERE OBSERVED IN DEVICE MEMORY. THE BATTERY VOLTAGE WAS NOTED TO BE 3.023 VOLTS AND THERAPY DELIVERY WAS NOTED TO BE UNAFFECTED. THE DEVICE HARDWARE WAS NOT DETECTING THE LOSS OF BATTERY ENERGY AND BECAUSE OF THAT, THE BATTERY STATUS INDICATORS WERE NOT REFLECTING THE DEPLETION CONDITION AND WERE INACCURATE, WHICH WAS THE REASON FOR THE FAULT MESSAGE. DEVICE REPLACEMENT WAS RECOMMENDED. AN INVASIVE PROCEDURE WAS PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    --

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313995 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| L| R 4086| E110| 0180