BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 3904383 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10154
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    September 9, 2013
    Report Date
    August 3, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    PMA / PMN Number
    P910073/S043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED POSSIBLE CAUSES OF THE INCREASED MEASUREMENTS. THE CALLER WILL DISCUSS THE CLINICAL OBSERVATIONS WITH THE PATIENT'S PHYSICIAN TO DETERMINE LONGTERM MANAGEMENT. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS SYSTEM, SHOCKING IMPEDANCE MEASUREMENTS WERE 102 OHMS IN TRIAD CONFIGURATION AND WITH THE PREVIOUS DEVICE, IMPEDANCE WAS 71 OHMS. A COMMANDED SHOCK WAS PERFORMED AND IMPEDANCE WAS THEN REPORTED TO BE 56 OHMS. SIX MONTHS LATER, THE IMPEDANCE HAD INCREASED TO 127-153 OHMS IN VARIOUS CONFIGURATIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384769 ENDOTAK RELIANCE G IMPLANTABLE LEAD LWS BOSTON SCIENTIFIC CORPORATION 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female 0184| 4086| 4518| H215| N164| 0184| H215| N164| 4518| 4086