BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE

    MDR report key: 19125987 · Received April 17, 2024

    Report

    Report Number
    19125987
    Event Type
    Malfunction
    Date Received
    April 17, 2024
    Date of Event
    October 12, 2023
    Report Date
    November 6, 2023
    Manufacturer
    INSPIRE MEDICAL SYSTEMS, INC.
    Product Code
    MNQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    UPON TESTING TONGUE MOTION NOT OBSERVED SO ADDITIONAL TESTING WAS PERFORMED WHERE WE HAD TO REPLACE 2 IMPLANTED ITEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1868491 INSPIRE STIMULATOR, HYPOGLOSSAL NERVE, IMPLANTED, APNEA MNQ INSPIRE MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male