BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 4131787 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14250
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 13, 2014
    Report Date
    August 12, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT, THE DEVICE WILL UNDERGO DETAILED ANALYSIS TO DETERMINE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS ICD WAS THOROUGHLY INSPECTED AND ANALYZED. EXTERNAL VISUAL INSPECTION OF THE DEVICE REVEALED NO ANOMALIES. REVIEW OF THE DEVICE MEMORY CONFIRMED THAT A LOW VOLTAGE ALERT WAS RECORDED. ALTHOUGH THE DEVICE MEMORY DIAGNOSTICS DEMONSTRATED THAT THE DAILY BATTERY VOLTAGE MEASUREMENTS DISPLAYED AN IRREGULAR PATTERN OF DISCHARGE, THE BATTERY VOLTAGE LEVEL AT EXPLANT WAS SUFFICIENT TO ENSURE THERAPY AVAILABILITY/DELIVERY WHILE THE DEVICE WAS IMPLANTED. THE DEVICE CASE WAS THEN OPENED TO FACILITATE ANALYSIS OF THE INTERNAL COMPONENTS. THE BATTERY WAS SEPARATED FROM THE OTHER DEVICE ELECTRONICS AND THE OVERALL CURRENT DRAW OF THE CIRCUITRY WAS MEASURED. A NORMAL CURRENT DRAIN WAS OBSERVED WITHIN THE CIRCUITRY. COLLECTIVELY, THE PATTERN OF IRREGULAR DAILY BATTERY VOLTAGE MEASUREMENTS IN CONJUNCTION WITH NORMAL POWER LEVELS AND DEVICE HYBRID CURRENT DRAW IS CONSISTENT WITH BEHAVIOR OF DEVICES WHERE A LATENT CURRENT LEAKAGE PATH HAS OCCURRED WITHIN THE BATTERY ITSELF, RESULTING IN A PARTIAL DEPLETION OF THE BATTERY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION OF THIS EVENT IS ON-GOING AS A REQUEST HAS BEEN MADE TO THE LOCAL REPRESENTATIVE FOR ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS HEALTH CARE PROFESSIONAL (HCP) CONTACTED BOSTON SCIENTIFIC'S TECHNICAL SERVICES (TS). ACCORDING TO THE HCP, THE PATIENT'S MONITORING SYSTEM DETECTED A CODE#1003. THE PATIENT WAS SEEN IN-CLINIC AND INTERROGATION OF THE DEVICE CONFIRMED THAT A CODE#1003 HAD BEEN DECLARED. STORED DATA FROM THE PATIENT'S MONITORING SYSTEM WAS REVIEWED BY BOSTON SCIENTIFIC'S IN-HOUSE ENGINEERING. A LOW VOLTAGE ALERT WAS DECLARED IN (B)(6) 2014. THE VOLTAGE IS CURRENTLY 2.998 VOLTS AND THERAPY DELIVERY IS UNAFFECTED. THE DEVICE HARDWARE IS NOT DETECTING THE LOSS OF BATTERY ENERGY. BECAUSE OF THIS, THE BATTERY STATUS INDICATORS ARE NOT REFLECTING THE DEPLETION CONDITION AND ARE INACCURATE. USING HISTORICAL DAILY BATTERY VOLTAGE MEASUREMENT DATA, THE DAILY DEVICE POWER FLUCTUATIONS WERE ESTIMATED. THE POWER FLUCTUATIONS APPEARS RANDOM, INTERMITTENT. BECAUSE THE BEHAVIOR OF THIS DEVICE IS UNPREDICTABLE, THE DEVICE SHOULD BE REPLACED AND RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY TESTING. AT THIS POINT, THE BATTERY HAS A SIGNIFICANT RESERVE CAPACITY. THE LOCAL REPRESENTATIVE WAS CONTACTED BY TS TO DISCUSS THE DATA ANALYSIS AND RECOMMENDATION FOR DEVICE REPLACEMENT. THE AVAILABLE INFORMATION SUGGESTS THAT THE DEVICE REMAINS IN-SERVICE.

    Description of Event or Problem · 1

    THE DEVICE WAS RECEIVED AT BOSTON SCIENTIFIC'S RETURN PRODUCTS DEPARTMENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS PRESENTED BACK TO THE ELECTROPHYSIOLOGY (EP) LABORATORY. THE DEVICE WAS EXPLANTED WITHOUT INCIDENT DUE TO PREMATURE BATTERY DEPLETION. THE DEVICE IS ENROUTE TO BOSTON SCIENTIFIC'S RETURN PRODUCTS DEPARTMENT FOR LABORATORY TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612965 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR 0185| E102