BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE

    MDR report key: 19114612 · Received April 16, 2024

    Report

    Report Number
    19114612
    Event Type
    Malfunction
    Date Received
    April 16, 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, THE PIECE OF EQUIPMENT DIDN'T WORK SO IT WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694934 INSPIRE STIMULATOR, HYPOGLOSSAL NERVE, IMPLANTED, APNEA MNQ INSPIRE MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male