BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRACEPT

    MDR report key: 23262439 · Received October 9, 2025

    Report

    Report Number
    3006630150-2025-08584
    Event Type
    Malfunction
    Date Received
    October 9, 2025
    Date of Event
    September 11, 2025
    Report Date
    February 20, 2026
    Manufacturer
    RELIEVANT MEDSYSTEMS, INC.
    Product Code
    GXI
    UDI-DI
    00852454006219
    PMA / PMN Number
    K222281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE, THE PHYSICIAN ENCOUNTERED HARD BONE AND THE CURVED CANNULA PEEK BROKE OFF INSIDE THE PATIENT. IT COULD NOT BE CONFIRMED WHETHER DEVICE FRAGMENTS WERE CONTAINED INSIDE THE BONE OR OUTSIDE THE BONE. IT WAS NOTED THAT A NEW INTRACEPT KIT WAS NOT OPENED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE, THE PHYSICIAN ENCOUNTERED HARD BONE AND THE CURVED CANNULA PEEK BROKE OFF INSIDE THE PATIENT. IT COULD NOT BE CONFIRMED WHETHER DEVICE FRAGMENTS WERE CONTAINED INSIDE THE BONE OR OUTSIDE THE BONE. IT WAS NOTED THAT A NEW INTRACEPT KIT WAS NOT OPENED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1577733 INTRACEPT PROBE, RADIOFREQUENCY LESION GXI RELIEVANT MEDSYSTEMS, INC. RLV 0055 37105997 00852454006219

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Unknown