BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2913357 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00158
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 11, 2012
    Report Date
    January 23, 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 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 LOW VOLTAGE BATTERY FAULTS (FAULT CODE 1001 AND 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 BEEPING TONES WERE NOTED BY THE PATIENT. THE PATIENT WAS SEEN IN CLINIC FIVE DAYS LATER. UPON INTERROGATION OF THE DEVICE NOTED A FAULT CODE "1003" MESSAGE NOTING VOLTAGE TOO LOW FOR PROJECTED REMAINING LONGEVITY. THE PATIENT HAD BEEN WORKING WITH ELECTRICAL TOOLS TRIMMING TREES THE DAY BEFORE THE BEEPING TONES WERE HEARD. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND NOTED THAT THIS FAULT WAS NOT LIKELY RELATED TO ANY USE OF TRIMMING TOOLS AND LIKELY THE DEVICE HAS AN INTERNAL CURRENT DRAIN THAT IS OUTSIDE OF NORMAL LIMITS. THE FIELD REPRESENTATIVE STATED THE DEVICE REMAINING LONGEVITY WAS 9.5 YEARS, HOWEVER, TS NOTED THAT THIS ESTIMATE WAS INACCURATE AS THE FAULT CODE SUGGESTED. TS RECOMMENDED IMMEDIATE REPLACEMENT OF THE DEVICE. A DEVICE REPLACEMENT PROCEDURE WAS SUCCESSFULLY PERFORMED THREE DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20757 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L| R E102| 0184