BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    INSPIRE MODEL 3028 IPG

    MDR report key: 11686454 · Received April 19, 2021

    Report

    Report Number
    3007666314-2021-00042
    Event Type
    Injury
    Date Received
    April 19, 2021
    Date of Event
    January 25, 2021
    Report Date
    April 19, 2021
    Manufacturer
    INSPIRE MEDICAL SYSTEMS
    Product Code
    MNQ
    UDI-DI
    10855728005656
    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

    PATIENT PRESENTED TO THE PHYSICIAN WITH SWELLING AT THE IPG SITE. PHYSICIAN PRESCRIBED ANTIBIOTICS (CLINDAMYCIN) ON (B)(6) 2020 TO ADDRESS SMALL HEMATOMA. THE PATIENT RETURNED TO THE PHYSICIAN WITH PERSISTENT IRRITATION AT THE IPG SITE. THE PHYSICIAN PRESCRIBED ANTIBIOTICS (BACTRIM) (B)(6) 2021. PERSISTENT IRRITATION CONTINUED AND THE PHYSICIAN EXPLANTED THE DEVICE ON (B)(6) 2021. CAUSE OF IRRITATION UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586979 INSPIRE MODEL 3028 IPG INSPIRE MODEL 3028 IPG MNQ INSPIRE MEDICAL SYSTEMS 3028 10855728005656

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R