BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRACEPT

    MDR report key: 23503805 · Received November 7, 2025

    Report

    Report Number
    3006630150-2025-10144
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Date of Event
    October 8, 2025
    Report Date
    November 7, 2025
    Manufacturer
    RELIEVANT MEDSYSTEMS, INC.
    Product Code
    GXI
    UDI-DI
    00852454006301
    PMA / PMN Number
    K222281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CLINICAL STUDY PATIENT EXPERIENCED THE PLASTIC TIP OF THE PEEK SHEATH ON THE CURVED CANNULA BREAKING DURING AN INTRACEPT PROCEDURE. THE DEVICE FRAGMENT WAS LEFT INSIDE THE PATIENT. IT IS UNKNOWN WHETHER THE DEVICE FRAGMENT WAS CONTAINED INSIDE OR OUTSIDE THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1781715 INTRACEPT PROBE, RADIOFREQUENCY LESION GXI RELIEVANT MEDSYSTEMS, INC. RLV 0045 36327641 00852454006301

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female