BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRACEPT

    MDR report key: 22868838 · Received August 21, 2025

    Report

    Report Number
    3006630150-2025-06738
    Event Type
    Injury
    Date Received
    August 21, 2025
    Date of Event
    July 21, 2025
    Report Date
    September 19, 2025
    Manufacturer
    RELIEVANT MEDSYSTEMS, INC.
    Product Code
    GXI
    UDI-DI
    00852454006226
    PMA / PMN Number
    K222281
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE DESCRIBE EVENT OR PROBLEM FIELD (B5) IN SECTION B, ADVERSE EVENT/PRODUCT PROBLEM, MANUFACTURER STATE (D3) IN SECTION D, SUSPECT MEDICAL DEVICE, AND DEVICE CODE (H6) IN SECTION H, DEVICE MANUFACTURERS ONLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INTRACEPT PROCEDURE WHERE THE L5 LUMBAR VERTEBRAE AND S1 SACRAL VERTEBRAE WERE ACCESSED, AND THE TARGETS WERE REACHED SUCCESSFULLY. WHILE ACCESSING L5, THE PROVIDER NOTED HE WAS IN THE PEDICLE AND BASED ON IMAGING, IT WAS POSSIBLE HE WAS ACCESSING THE INFERIOR PORTION OF THE PEDICLE. AFTER THE PROCEDURE, THE PATIENT EXPERIENCED MINOR WEAKNESS IN THEIR RIGHT LEG. THE PATIENT ELECTED TO GO TO THE HOSPITAL FOR OBSERVATION DUE TO LACK OF SUPPORT AT HOME. THE PATIENT WAS RELEASED WITHIN TWENTY-FOUR HOURS. IT WAS NOTED BY THE PROVIDER THAT THE PATIENT HAS SOME PSYCHIATRIC ISSUES, BUT THE PATIENT HAS RECOVERED. THE PHYSICIAN ASSESSED THAT THE PATIENTS NERVE MAY HAVE BEEN AGGRAVATED DURING THE PROCEDURE. THE PATIENT WAS IN GOOD HEALTH AND DID NOT HAVE ANY FURTHER ISSUES. THE DEVICES WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INTRACEPT PROCEDURE WHERE THE L5 LUMBAR VERTEBRAE AND S1 SACRAL VERTEBRAE WERE ACCESSED, AND THE TARGETS WERE REACHED SUCCESSFULLY. WHILE ACCESSING L5, THE PROVIDER NOTED HE WAS IN THE PEDICLE AND BASED ON IMAGING, IT WAS POSSIBLE HE WAS ACCESSING THE INFERIOR PORTION OF THE PEDICLE. AFTER THE PROCEDURE, THE PATIENT EXPERIENCED MINOR WEAKNESS IN THEIR RIGHT LEG. THE PATIENT ELECTED TO GO TO THE HOSPITAL FOR OBSERVATION DUE TO LACK OF SUPPORT AT HOME. THE PATIENT WAS RELEASED WITHIN TWENTY-FOUR HOURS. THE PATIENT WAS IN GOOD HEALTH AND DID NOT HAVE ANY FURTHER ISSUES. THE DEVICES WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192800 INTRACEPT PROBE, RADIOFREQUENCY LESION GXI RELIEVANT MEDSYSTEMS, INC. RLV 0055 36509579 00852454006226

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Hospitalization