BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3904165 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09135
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 30, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOWING RETURN AND COMPLETION OF LABORATORY ANALYSIS, THIS EVENT WILL BE FURTHER UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY. REVIEW OF THE DEVICE MEMORY CONFIRMED THAT CODE 1003 HAD BEEN 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 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.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING INTERROGATION, THIS DEVICE TRIGGERED A CODE INDICATIVE OF AN INTERNAL BATTERY VOLTAGE TOO LOW, TO SUPPORT THE PROJECTED REMAINING CAPACITY. THE PHYSICIAN CONTACTED BOSTON SCIENTIFIC FOR REVIEW OF THE OBSERVED BEHAVIOR. THE MANUFACTURES RECOMMENDATIONS: INSTRUCT THE PATIENT TO RETURN FOR PRODUCT REPLACEMENT AS DATA ANALYSIS INDICATES THE DEVICE IS MALFUNCTIONING. SUBSEQUENTLY, THE PATIENT RETURNED AND THE DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED WITH ANOTHER BOSTON SCIENTIFIC DEVICE. THE EXPLANTED UNIT IS INTENDED TO BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382952 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND F103

    Patients

    Seq Age Sex Outcome Treatment
    1 Congenital Anomaly| H| L 0283| F103