BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE MODEL 3028

    MDR report key: 16598049 · Received March 22, 2023

    Report

    Report Number
    MW5115929
    Event Type
    Malfunction
    Date Received
    March 22, 2023
    Date of Event
    March 2, 2023
    Report Date
    March 20, 2023
    Manufacturer
    INSPIRE MEDICAL SYSTEMS, INC.
    Product Code
    MNQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MRI (MAGNETIC RESONANCE IMAGING) SAFETY ISSUE: PATIENT WITH INSPIRE IMPLANT MODEL 3028 SCANNED FOR MRI HEAD, WITH RECEIVE ONLY HEAD COIL ON A 1.5T. DEVICE TURNED ON SPONTANEOUSLY WHEN PATIENT WAS PULLED OUT OF BORE FOR AN IV START AFTER BEING SCANNED FOR ~20 MINS. PATIENT WAS TALKING TO TECH WHEN HER DEVICE JUST TURNED ON. TECH HAD TO TAKE PATIENT TO ZONE 3 AND THEN TO PATIENT LOCKER TO RETRIEVE THE REMOTE TO TURN DEVICE OFF. ALL PARAMETERS WERE MET PER MFR'S REQUIREMENTS BUT DEVICE TURNED OUT SOME HOW IN ZONE 4. DEVICE WAS CHECKED BEFORE EXAM WITH PATIENT AND TECH CONFIRMING DEVICE WAS OFF BEFORE PROCEEDING TO ZONE 3, THEN 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375559 INSPIRE MODEL 3028 STIMULATOR, HYPOGLOSSAL NERVE, IMPLANTED, APNEA MNQ INSPIRE MEDICAL SYSTEMS, INC. 3028

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Other