BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRACEPT

    MDR report key: 24841827 · Received April 10, 2026

    Report

    Report Number
    3006630150-2026-02216
    Event Type
    Malfunction
    Date Received
    April 10, 2026
    Date of Event
    March 11, 2026
    Report Date
    May 7, 2026
    Manufacturer
    RELIEVANT MEDSYSTEMS, INC.
    Product Code
    GXI
    UDI-DI
    00852454006424
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE, THE L2, L3, AND L4 LUMBAR VERTEBRAE WERE COMPLETED NORMALLY, HOWEVER, WHEN L5 WAS ATTEMPTED, THE PATIENT HAD HARD BONE AND THE FIRST ATTEMPT WENT TOO ANTERIOR. THE SECOND ATTEMPT WAS ALSO ANTERIOR AND THE CURVED CANNULA ASSEMBLY HAD BEEN REINSERTED INCORRECTLY. ABLATION WAS STARTED ON L5, HOWEVER, THE PHYSICIAN ENCOUNTERED IMPEDANCES. WHEN THE PHYSICIAN PULLED OUT THE CURVED CANNULA ASSEMBLY, SOME OF THE CURVED CANNULA PEEK WAS BROKEN OFF AND LEFT INSIDE THE PATIENT. NO SMALLER PIECES WERE SEEN AND THE CURVED CANNULA PEEK WAS MOST LIKELY BROKEN OFF INSIDE THE PATIENT. L5 WAS COMPLETED ON THE LEFT SIDE AS NORMAL. IT IS UNKNOWN WHETHER THE DEVICE FRAGMENTS ARE CONTAINED INSIDE OR OUTSIDE THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383654 INTRACEPT PROBE, RADIOFREQUENCY LESION GXI RELIEVANT MEDSYSTEMS, INC. RLV 0065 38632678 00852454006424

    Patients

    Seq Age Sex Outcome Treatment
    1