BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE STIMULATION LEAD

    MDR report key: 6987670 · Received October 30, 2017

    Report

    Report Number
    3007666314-2017-00019
    Event Type
    Injury
    Date Received
    October 30, 2017
    Date of Event
    September 27, 2017
    Report Date
    February 27, 2018
    Manufacturer
    INSPIRE MEDICAL SYSTEMS INC
    Product Code
    MNQ
    UDI-DI
    00855728005017
    PMA / PMN Number
    P130008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS IS A FOLLOW UP REPORT TO MDR REPORT # 3007666314-2017-00019, FILED TO UPDATE THE REPORT WITH THE INFORMATION THAT THE INJURY COMPLETELY RESOLVED WITHOUT INTERVENTION.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH A DROOPY RIGHT LOWER LIP. PHYSICIAN REPORTED THAT PATIENT'S MARGINAL MANDIBULAR NERVE WAS DAMAGED DURING IMPLANT, AND THE NERVE MAY OR MAY NOT IMPROVE DURING THE HEALING PROCESS. IMPLANT WAS STILL ACTIVATED AS PLANNED. THE PHYSICIAN DID NOT THINK THAT IT HAD ANY BEARING ON THE FUNCTIONALITY OF THE INSPIRE DEVICE AND WANTED TO MOVE FORWARD, AS DID THE PATIENT. NO NEURAPRAXIA OF THE TONGUE WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767301 INSPIRE STIMULATION LEAD NEUROSTIMULATION LEAD MNQ INSPIRE MEDICAL SYSTEMS INC 4063 00855728005017

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S