BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE

    MDR report key: 8153164 · Received December 11, 2018

    Report

    Report Number
    3007666314-2018-00050
    Event Type
    Injury
    Date Received
    December 11, 2018
    Date of Event
    December 5, 2018
    Report Date
    December 11, 2018
    Manufacturer
    INSPIRE MEDICAL SYSTEMS INC
    Product Code
    MNQ
    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

    THE PATIENT STATED THAT HE HAD NOTICED A LISP AFTER HIS IMPLANT SURGERY WHICH HAS IMPROVED WITH TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990827 INSPIRE UPPER AIRWAY STIMULATION MNQ INSPIRE MEDICAL SYSTEMS INC 4063

    Patients

    Seq Age Sex Outcome Treatment
    1 Other