BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADLINK TECHNOLOGY, INC INSPIRE TABLET

    MDR report key: 15824696 · Received November 18, 2022

    Report

    Report Number
    15824696
    Event Type
    Malfunction
    Date Received
    November 18, 2022
    Date of Event
    September 27, 2022
    Report Date
    November 1, 2022
    Manufacturer
    INSPIRE MEDICAL SYSTEMS INC.
    Product Code
    MNQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS HERE FOR A HGNS (HYPOGLOSSAL NERVE STIMULATION) DOWNLOAD, AND DURING THE SENSING CHECK. THE DEVICE HAD ELECTRICAL INTERFERENCE. WHEN THIS HAPPENED, THIS LEFT THE PATIENT'S TONGUES PROTRUDING OUT OF HIS MOUTH. WE HAD TO POWER DOWN THE PROGRAMMER TO GET HIS HGNS BACK TO FUNCTIONING CORRECTLY. I HAD TO GET ANOTHER PROGRAMMER TO TURN OFF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229964 ADLINK TECHNOLOGY, INC INSPIRE TABLET STIMULATOR, HYPOGLOSSAL NERVE, IMPLANTED, APNEA MNQ INSPIRE MEDICAL SYSTEMS INC. IMT-BT

    Patients

    Seq Age Sex Outcome Treatment
    1 17520 DA Male Other