BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2911515 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15843
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 19, 2012
    Report Date
    January 4, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0026-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE ICD REMAINS IMPLANTED AND IN SERVICE. ONCE ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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

    ONCE THE ICD IS RECEIVED AND ANALYSIS COMPLETED, THIS REPORT WILL BE UPDATED.

    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 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED A FAULT CODE INDICATING THAT THE VOLTAGE WAS TOO LOW FOR PROJECTED REMAINING CAPACITY. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED FOR TECHNICAL ASSISTANCE. A TS CONSULTANT DISCUSSED THAT THE FAULT OCCURS WHEN THE BATTERY VOLTAGE IS LESS THAN EXPECTED BASED ON THE ESTIMATED APPROXIMATE TIME TO EXPLANT. A MEMORY DOWNLOAD COULD BE PERFORMED AND SENT FOR ANALYSIS IN ORDER TO HAVE THE DEPLETION RATE ASSESSED. IT WAS ALSO DISCUSSED THAT THE ICD SHOULD BE REPLACED AS SOON AS POSSIBLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED AND THIS ICD WAS SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE ICD WILL BE RETURNED FOR LABORATORY ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    --

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17663 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R