BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE UPPER AIRWAY STIMULATION

    MDR report key: 6919244 · Received October 5, 2017

    Report

    Report Number
    3007666314-2017-00018
    Event Type
    Injury
    Date Received
    October 5, 2017
    Date of Event
    June 9, 2017
    Report Date
    October 5, 2017
    Manufacturer
    INSPIRE MEDICAL SYSTEMS INC
    Product Code
    MNQ
    UDI-DI
    00855728005024
    PMA / PMN Number
    P130008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NO EVIDENCE OF MALFUNCTION BUT THE PATIENT DID EXPERIENCE AN INFECTION I THE IPG POCKET. UPDATE WAS RECEIVED 9/14/2017 - PATIENT HAD THEIR SYSTEM EXPLANTED, AND PATIENT'S INFECTION RESOLVED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694591 INSPIRE UPPER AIRWAY STIMULATION IMPLANTABLE PULSE GENERATOR MNQ INSPIRE MEDICAL SYSTEMS INC 3024 00855728005024

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention