BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3241483 · Received July 22, 2013

    Report

    Report Number
    2124215-2013-11598
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 24, 2013
    Report Date
    August 21, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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. ALTHOUGH THE DEVICE MEMORY DIAGNOSTICS DEMONSTRATED THAT THE DAILY BATTERY VOLTAGE MEASUREMENTS DISPLAYED AN IRREGULAR PATTERN OF DISCHARGE, THE BATTERY VOLTAGE LEVEL AT EXPLANT 3.009 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.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT HEARD BEEPING TONES WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WHICH DISPLAYED A FAULT CODE UPON INTERROGATION. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THE MECHANISM BEHIND THE FAULT CODE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PATIENT UNDERWENT A REPLACEMENT PROCEDURE AND THIS PRODUCT WAS EXPLANTED AND REPLACED. THE DEVICE WILL BE RETURNED FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340103 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F110

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R