BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRACEPT

    MDR report key: 23762848 · Received December 9, 2025

    Report

    Report Number
    3006630150-2025-11296
    Event Type
    Injury
    Date Received
    December 9, 2025
    Date of Event
    November 14, 2025
    Report Date
    May 21, 2026
    Manufacturer
    RELIEVANT MEDSYSTEMS, INC.
    Product Code
    GXI
    UDI-DI
    00852454006301
    PMA / PMN Number
    K222281
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INTERCEPT PROCEDURE, THE PATIENTS PULSE AND BLOOD PRESSURE DROPPED AFTER THE FIRST VERTEBRAL LEVEL WAS COMPLETED. THE PATIENT STOPPED BREATHING AND THE PROCEDURE WAS IMMEDIATELY ABORTED. THE PATIENT WAS TURNED INTO A SUPINE POSITION, INTUBATED, AND CHEST COMPRESSIONS WERE PERFORMED TO RESTORE THE PATIENTS PULSE AND BLOOD PRESSURE. THE PATIENT WAS GIVEN MEDICATION TO REVERSE ANESTHESIA AND RAISE THEIR HEART RATE. THE PATIENT WAS UNCONSCIOUS FOLLOWING THE PROCEDURE AND THE MEDICAL TEAM ASSESSED THAT THE PATIENTS POOR LUNG HEALTH AND MEDICAL HISTORY OF RESPIRATORY DEPRESSION AND HYPOXIA WERE BELIEVED TO BE RELATED TO THE PATIENTS COMPLICATIONS. THE PATIENT WAS SUCCESSFULLY STABILIZED AND TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). AFTER THE PATIENT WAS ADMITTED TO THE ICU, THE PATIENT DID NOT REGAIN CONSCIOUSNESS. THE PATIENT EXHIBITED MINIMAL BRAINWAVE ACTIVITY AND WAS THOUGHT TO HAVE HYPOXIC BRAIN DAMAGE. THE PATIENT WAS TAKEN OFF LIFE SUPPORT AND PASSED AWAY. THERE WERE NO REPORTED DEVICE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19111 INTRACEPT PROBE, RADIOFREQUENCY LESION GXI RELIEVANT MEDSYSTEMS, INC. RLV 0045 00852454006301

    Patients

    Seq Age Sex Outcome Treatment
    1