BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRACEPT RF PROBE

    MDR report key: 22877901 · Received August 22, 2025

    Report

    Report Number
    3006630150-2025-06782
    Event Type
    Injury
    Date Received
    August 22, 2025
    Date of Event
    July 30, 2025
    Report Date
    August 22, 2025
    Manufacturer
    RELIEVANT MEDSYSTEMS, INC.
    Product Code
    GXI
    UDI-DI
    00852454006219
    PMA / PMN Number
    K180369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM (ER) DUE TO EXPERIENCING NEW POST-OPERATIVE LEG PAIN THAT WAS SEVERE. THE PATIENT WAS SEEN BY MULTIPLE SPECIALISTS WITH NO CLEAR ETIOLOGY. THE PATIENT LATER WENT TO A CLINIC TO SEE A PHYSICIAN. THE PATIENTS LEG WEAKNESS AND PAIN SYMPTOMS WERE RESOLVED. THE PATIENT STATES THERE IS A SMALL AREA OF NUMBNESS IN THEIR FOOT. IT WAS NOTED THAT THE PATIENTS INTRACEPT PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO REPORTED DEVICE ISSUES. IN ADDITION, THE DEVICE WAS DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2495507 INTRACEPT RF PROBE PROBE, RADIOFREQUENCY LESION GXI RELIEVANT MEDSYSTEMS, INC. RLV 0015 36686272 00852454006219

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Other