BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE MODEL 3028 IPG

    MDR report key: 11987674 · Received June 11, 2021

    Report

    Report Number
    3007666314-2021-00077
    Event Type
    Injury
    Date Received
    June 11, 2021
    Date of Event
    May 28, 2021
    Report Date
    June 11, 2021
    Manufacturer
    INSPIRE MEDICAL SYSTEMS
    Product Code
    MNQ
    UDI-DI
    10855728005656
    PMA / PMN Number
    P130008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT PRESENTED TO PHYSICIAN WITH HEMATOMA TWO WEEKS AFTER IMPLANT SURGERY. PHYSICIAN PRESCRIBED ANTIBIOTICS TO ADDRESS THE HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878021 INSPIRE MODEL 3028 IPG INSPIRE MODEL 3028 IPG MNQ INSPIRE MEDICAL SYSTEMS 3028 10855728005656

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R