BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE UPPER AIRWAY STIMULATION

    MDR report key: 8152907 · Received December 11, 2018

    Report

    Report Number
    3007666314-2018-00049
    Event Type
    Injury
    Date Received
    December 11, 2018
    Date of Event
    December 4, 2018
    Report Date
    May 6, 2019
    Manufacturer
    INSPIRE MEDICAL SYSTEMS INC
    Product Code
    MNQ
    UDI-DI
    10855728005465
    PMA / PMN Number
    P130008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOW UP REPORT TO 3007666314-2018-00049: PATIENT HAD EXPERIENCED A SLIGHT LISP FOLLOWING IMPLANT SURGERY. THE LISP FULLY RESOLVED ON ITS OWN WITH OUR INTERVENTION.

    Description of Event or Problem · 1

    PATIENT HAS BEEN EXPERIENCING A SLIGHT LISP FOLLOWING HIS IMPLANT HIS SURGERY WHICH OCCURRED 2 MONTHS EARLIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989449 INSPIRE UPPER AIRWAY STIMULATION UPPER AIRWAY STIMULATION MNQ INSPIRE MEDICAL SYSTEMS INC 3028 10855728005465

    Patients

    Seq Age Sex Outcome Treatment
    1 Other