BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE

    MDR report key: 19078434 · Received April 10, 2024

    Report

    Report Number
    19078434
    Event Type
    Malfunction
    Date Received
    April 10, 2024
    Date of Event
    March 19, 2024
    Report Date
    March 19, 2024
    Manufacturer
    INSPIRE MEDICAL SYSTEMS, INC.
    Product Code
    MNQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    UPON REMOVAL OF INSPIRE GENERATOR, SURGEON NOTICED BURNED ELECTRODE WITHIN GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413074 INSPIRE STIMULATOR, HYPOGLOSSAL NERVE, IMPLANTED, APNEA MNQ INSPIRE MEDICAL SYSTEMS, INC. AIR340606C

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male