BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE MODEL 4063 STIMULATION LEAD

    MDR report key: 6139837 · Received December 1, 2016

    Report

    Report Number
    3007666314-2016-00013
    Event Type
    Injury
    Date Received
    December 1, 2016
    Date of Event
    November 18, 2016
    Report Date
    December 1, 2016
    Manufacturer
    INSPIRE MEDICAL SYSTEMS INC.
    Product Code
    MNQ
    UDI-DI
    00855728005017
    PMA / PMN Number
    P130008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IMPLANTED AND IN USE.

    Description of Event or Problem · 1

    MUCOSAL TEAR IN FLOOR OF THE MOUTH EITHER HAPPENING FROM THE BLUE NIM PROBE (ANOTHER MANUFACTURERS DEVICE) USED TO MONITOR GENIOHYOID OR FROM NERVE DISSECTION DUE TO CHALLENGING ANATOMY WHILE IMPLANTING THE MODEL 4063 STIMULATION LEAD. THE DOCTOR PLACED 3 DISPOSABLE STITCHES IN THE FLOOR OF THE PATIENTS MOUTH AND SENT HIM HOME ON ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789990 INSPIRE MODEL 4063 STIMULATION LEAD NEUROSTIMULATION LEAD MNQ INSPIRE MEDICAL SYSTEMS INC. MODEL 4063 00855728005017

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NIM DEVICE USED TO IDENTIFY NERVE BRANCHES