BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    INSPIRE MODEL 3028 IPG

    MDR report key: 11645644 · Received April 9, 2021

    Report

    Report Number
    3007666314-2021-00033
    Event Type
    Injury
    Date Received
    April 9, 2021
    Date of Event
    March 19, 2021
    Report Date
    April 9, 2021
    Manufacturer
    INSPIRE MEDICAL SYSTEMS
    Product Code
    MNQ
    UDI-DI
    10855728005656
    PMA / PMN Number
    P130008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT PRESENTED TO PHYSICIAN WITH INFECTION. PHYSICIAN SURGICALLY REMOVED THE SYSTEM TO ADDRESS THE INFECTION ON (B)(6) 2021, RESOLVING THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540928 INSPIRE MODEL 3028 IPG INSPIRE MODEL 3028 IPG MNQ INSPIRE MEDICAL SYSTEMS 3028 10855728005656

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R