BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE MODEL 3028 IPG

    MDR report key: 17861588 · Received October 3, 2023

    Report

    Report Number
    3007666314-2023-00302
    Event Type
    Injury
    Date Received
    October 3, 2023
    Date of Event
    January 12, 2024
    Report Date
    January 30, 2024
    Manufacturer
    INSPIRE MEDICAL SYSTEMS
    Product Code
    MNQ
    UDI-DI
    10855728005915
    PMA / PMN Number
    P130008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT PRESENTED BACK TO THE PHYSICIAN WITH PERSISTENT THROAT PAIN. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND REMOVED THE ENTIRE SYSTEM.

    Description of Event or Problem · 0

    PATIENT PRESENTED TO THE PHYSICIAN WITH RIGHT SIDE OTALGIA AND BURNING THROAT PAIN. INSPIRE SYSTEM HAS NOT BEEN ACTIVATED FOR THE PATIENT AND IS CURRENTLY NOT USING INSPIRE THERAPY. PHYSICIAN PRESCRIBED PAIN MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417078 INSPIRE MODEL 3028 IPG INSPIRE MODEL 3028 IPG MNQ INSPIRE MEDICAL SYSTEMS 3028 10855728005915

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention