BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE STIMULATION LEAD FOR OBSTRUCTIVE SLEEP APNEA

    MDR report key: 12336917 · Received August 17, 2021

    Report

    Report Number
    MW5103308
    Event Type
    Malfunction
    Date Received
    August 17, 2021
    Date of Event
    August 9, 2021
    Report Date
    August 13, 2021
    Manufacturer
    INSPIRE MEDICAL SYSTEMS, INC.
    Product Code
    MNQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IMPLANTED ELECTRODE FOUND TO BE NOT PROPERLY FUNCTIONING WITH DIAGNOSTIC TESTING BY VENDOR IMMEDIATELY POST IMPLANTATION BY SURGEON. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231798 INSPIRE STIMULATION LEAD FOR OBSTRUCTIVE SLEEP APNEA STIMULATOR, HYPOGLOSSAL NERVE, IMPLANTED, APNEA MNQ INSPIRE MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR