BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3041057 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01821
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    December 13, 2012
    Report Date
    February 1, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MEMORY UPLOAD CONFIRMED THAT A LOW VOLTAGE FAULT WAS DECLARED IN (B)(6) 2013 DUE TO THREE DAILY VOLTAGES BEING BELOW THE THRESHOLD OF 3.025 VOLTS. THE VOLTAGE IS CURRENTLY 3.032 VOLTS AND THERAPY DELIVERY IS UNAFFECTED. USING THE LAST YEARS' 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 STEADY WITH AN ADDITIONAL CURRENT DRAIN OF MORE THAN 12UA OVER THE EXPECTED NOMINAL VALUE OF 10UA. TO DATE, THE BEHAVIOR APPEARS INCONSISTENT OVER TIME, HOWEVER, THE FAILURE MODE MAY CHANGE UNPREDICTABLY. AT THIS POINT, THE BATTERY DOES HAVE A SIGNIFICANT RESERVE CAPACITY. THE DATA INDICATES THAT THERE IS SUFFICIENT RESERVE FOR THE DEVICE MAINTAIN NORMAL THERAPY FUNCTIONS FOR 1 WEEKS' TIME. SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS PRESENTED TO THE ELECTROPHYSIOLOGY (EP) LABORATORY. THE DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED. THE DEVICE WAS RECEIVED AT BOSTON SCIENTIFIC'S RETURN PRODUCTS DEPARTMENT. THE DEVICE IS CURRENTLY UNDERGOING LABORATORY TESTING TO DETERMINE ROOT CAUSE.

    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 (3.021 VOLTS) 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. A REVIEW OF THE STORED EPISODES IDENTIFIED NOISE ON BOTH THE SHOCK AND RV CHANNELS FOR EPISODES RECORDED ON (B)(6) 2012. A LEAKAGE ON LEAD FAULT WAS ALSO RECORDED ON (B)(6) 2012 CORRESPONDING TO EPISODE#V-45. THE DEVICE WAS PUT THROUGH AND PASSED AUTOMATIC DIAGNOSTIC TESTING THAT VERIFIED THE PERFORMANCE OF DEFIBRILLATION, PACING, AND SENSING FUNCTION OF THE DEVICE. ALL SEAL PLUGS ARE INTACT AND ALL OF THE SETSCREWS OPERATED NORMALLY. THE DEVICE PASSED PIN GAUGE TESTING. THE REPORTED NOISE AND OVERSENSING ALLEGATION COULD NOT BE CONFIRMED AS THE DEVICE PASSED BOTH MECHANICAL HEADER TESTS AND ELECTRICAL SENSING TESTS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS HEALTH CARE PROFESSIONAL (HCP) CONTACTED BOSTON SCIENTIFIC'S TECHNICAL SERVICES (TS) TO REPORT THAT THIS DEVICE DISPLAYED A FAULT CODE#1003 (VOLTAGE TOO LOW FOR PROJECTED REMAINING CAPACITY). TS DISCUSSED THE ISSUE AND RECOMMENDED THAT THIS DEVICE SHOULD BE REPLACED. THE HCP WAS PLANNING TO PERFORM A MEMORY UPLOAD AND WILL DELIVER TO THE LOCAL REPRESENTATIVE FOR RETURN AND ANALYSIS. THE LOCAL REPRESENTATIVE CONTACTED TS TO DISCUSS THE ISSUE AND WAS ENROUTE TO THE CLINIC TO PICK-UP THE MEMORY UPLOAD. THE PATIENT HAS BEEN SCHEDULED FOR DEVICE REPLACEMENT. THE LOCAL REPRESENTATIVE COMMENTED THAT THIS PATIENT DID RECEIVED SHOCK THERAPY ON (B)(6) 2012. A REVIEW OF THE EPISODE IDENTIFIED NOISE ON THE ELECTROGRAM. TS SUGGESTED THAT LEAD DATA SHOULD BE EVALUATED TO DETERMINE IF ADDITIONAL INTERVENTION IS REQUIRED. THE LOCAL REPRESENTATIVE REVIEWED THE EPISODE AGAIN AND REPORTED THAT JUST PRIOR TO SHOCK DELIVERY, THE PATIENT WAS IN THE BATHROOM AND WAS BEARING DOWN. THE PATIENT BECAME 'CLAMMY' AND WAS PRE-SYNCOPAL. THE EPISODE WAS FURTHER DISCUSSED BY MEMBERS OF THE TS TEAM AND IN-HOUSE ENGINEERING. THE DEVICE HAD 17 EPISODES ON (B)(6) 2012. THREE OF THESE EPISODES PROVIDED ATP THERAPY AND ONE ALSO DELIVERED A 21J SHOCK. THEY ALL APPEAR TO HAVE NOISE ON BOTH THE VENTRICULAR AND SHOCK CHANNELS DURING THE EPISODES. SOME OF THE NOISE MAY HAVE CAUSED OVERSENSING ALTHOUGH THE EPISODE WITH THE SHOCK APPEARS TO HAVE A FAST INTRINSIC RATE. THE DEVICE ALSO RECORDED A LEAKAGE ON LEAD FAULT THIS TYPE OF FAULT MAY BE CAUSED BY THE DEVICE DETECTING ENERGY FROM AN EXTERNAL SOURCE. IT WAS CONCLUDED THAT THIS 12-YEAR OLD LEAD SHOULD BE THOROUGHLY EVALUATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143896 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| O 0147| E102| 1860