BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3053245 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04811
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 18, 2013
    Report Date
    May 29, 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

    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 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.

    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

    THE DEVICE REMAINS IMPLANTED AT THIS TIME. A BOSTON SCIENTIFIC TECHNICAL SERVICE AGENT RECOMMENDED A DEVICE REPLACEMENT. IF A REVISION IS PERFORMED AND THE PRODUCT IS RETURNED TO BOSTON SCIENTIFIC LABORATORY ANALYSIS WILL BE PERFORMED TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT AND A FINAL REPORT WILL BE SENT WITH LABORATORY FINDINGS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW UP, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REVEALED A FAULT CODE OF 1003 DURING INTERROGATION. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AGENT WAS CONTACTED. THE AGENT EXPLAINED THAT THE FAULT CODE 1003 WAS DUE TO A LOW BATTERY VOLTAGE FAULT ON THE DEVICE. THE AGENT ADVISED THAT THE BATTERY VOLTAGE IS LESS THAN EXPECTED BASED ON APPROXIMATE TIME TO EXPLANT AND THERAPY IS NOT COMPROMISED AT THIS TIME. IT WAS RECOMMENDED TO SCHEDULE THE PATIENT FOR DEVICE REPLACEMENT AND SEND A SAVE TO DISK TO TS FOR REVIEW. AFTER REVIEW, THE ENGINEER'S ANALYSIS CONFIRMED THE LOW VOLTAGE FAULT CODE AND CONCLUDED THAT THE DEVICE IS MALFUNCTIONING. THERAPY DELIVERY WITHIN THE DEVICE IS CURRENTLY UNAFFECTED. A LONGEVITY CALCULATION WAS PERFORMED AND REVEALED POWER LEVELS WITHIN THE DEVICE ARE NORMAL. THE DEVICE HARDWARE IS NOT DETECTING THE LOSS OF BATTERY ENERGY AND BECAUSE OF THIS, THE BATTERY STATUS INDICATORS ARE NOT REFLECTING THE DEPLETION CONDITION AND ARE INACCURATE; THIS IS THE REASON FOR THE FAULT. THE AGENT CONCLUDED THAT THE DEVICE SHOULD BE REPLACED AND RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS AS IT IS UNKNOWN HOW LONG THERAPY WILL REMAIN AVAILABLE TO THE PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN SERVICE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155407 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening