BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE MODEL 4063 STIMULATION LEAD

    MDR report key: 24272847 · Received February 5, 2026

    Report

    Report Number
    3007666314-2026-01008
    Event Type
    Injury
    Date Received
    February 5, 2026
    Date of Event
    January 28, 2026
    Report Date
    February 5, 2026
    Manufacturer
    INSPIRE MEDICAL SYSTEMS
    Product Code
    MNQ
    UDI-DI
    10855728005793
    PMA / PMN Number
    P130008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT PRESENTED TO THE PHYSICIAN WITH ONGOING OCCIPITAL NEURALGIA/HEADACHES SINCE THE IMPLANT PROCEDURE. PHYSICIAN PRESCRIBED ANTI-INFLAMMATORY MEDICATION, AND WILL RE-EVALUATE THE NEXT STEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328927 INSPIRE MODEL 4063 STIMULATION LEAD INSPIRE MODEL 4063 STIMULATION LEAD MNQ INSPIRE MEDICAL SYSTEMS 4063SI 10855728005793

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention