BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3043140 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-01971
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 17, 2013
    Report Date
    February 28, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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 FAULT CODE 1003 WAS RECORDED ON (B)(6) 2013. 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

    UPON RECEIPT, THE DEVICE WILL UNDERGO LABORATORY TESTING TO DETERMINE ROOT CAUSE.

    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 PHYSICIAN CONTACTED THE LOCAL REPRESENTATIVE TO REPORT THAT THIS PATIENT'S MONITORING SYSTEM DETECTED A YELLOW ALERT (VOLTAGE TOO LOW FOR PROJECTED REMAINING CAPACITY) THAT WAS DETECTED ON (B)(6) 2013. THE LOCAL REPRESENTATIVE CONTACTED BOSTON SCIENTIFIC'S TECHNICAL SERVICES (TS) TO DISCUSS THE ISSUE. TS INFORMED THE LOCAL REPRESENTATIVE THAT THE DEVICE SHOULD BE EXPLANTED AND REPLACED. SUBSEQUENTLY, THE LOCAL REPRESENTATIVE CONTACTED TS TO DISCUSS THE ISSUE AGAIN. TS SUGGESTED THAT A MEMORY UPLOAD COULD BE PERFORMED TO OBTAIN A BETTER UNDERSTANDING OF THE BATTERY'S CONDITION. THE PHYSICIAN PERMITTED BOSTON SCIENTIFIC TO VIEW DATA STORED IN THE PATIENT'S MONITORING SYSTEM. A REVIEW OF THE STORED DATA CONFIRMED THAT A LOW VOLTAGE FAULT WAS DECLARED ON (B)(6) 2013 DUE TO THREE DAILY VOLTAGES BEING BELOW THE THRESHOLD OF 3.025 VOLTS. THE VOLTAGE HAS CURRENTLY RECOVERED TO 3.005 VOLTS AND THERAPY DELIVERY IS UNAFFECTED. USING THE LAST FEW WEEKS' WORTH OF DAILY BATTERY VOLTAGE MEASUREMENT DATA, THE ESTIMATED TRUE DEPTH OF BATTERY DISCHARGE TO OBTAIN AN ESTIMATE OF THE FAULT CURRENT WAS PLOTTED. THE CURRENT APPEARS INTERMITTENT/IRREGULAR WITH A PEAK ADDITIONAL CURRENT DRAIN OF 7000UA OVER THE EXPECTED NOMINAL VALUE OF 10UA. TO DATE, THE BEHAVIOR APPEARS INCONSISTENT OVER TIME. THE FAILURE MODE MAY CHANGE UNPREDICTABLY. AT THIS POINT, THE BATTERY DOES HAVE A SIGNIFICANT RESERVE CAPACITY AND THE VOLTAGE IS RECOVERING. THE DEVICE DOES NOT APPEAR TO BE ACTIVELY DEPLETING AT THIS POINT. HOWEVER, IF THE FAULT CURRENT WERE TO COME BACK AT THE PREVIOUSLY OBSERVED LEVEL, THE DEVICE MAY LOSE THE ABILITY TO DELIVER THERAPY IN A MATTER OF A FEW DAYS. TS WAS INFORMED THAT THE PATIENT HAS BEEN SCHEDULED FOR DEVICE REPLACEMENT THE NEXT DAY. BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS PRESENTED TO THE ELECTROPHYSIOLOGY (EP) LABORATORY. THE DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145796 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R E102| 0185