BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRACEPT

    MDR report key: 22373413 · Received July 1, 2025

    Report

    Report Number
    3006630150-2025-05024
    Event Type
    Malfunction
    Date Received
    July 1, 2025
    Date of Event
    May 12, 2025
    Report Date
    July 1, 2025
    Manufacturer
    RELIEVANT MEDSYSTEMS, INC.
    Product Code
    GXI
    UDI-DI
    00852454006301
    PMA / PMN Number
    K222281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE, THE PROBE EXHIBITED HIGH IMPEDANCE AND IT WAS FOUND THAT THE CURVED CANNULA HAD A SHEARED PEEK AT THE DISTAL TIP. THE L5 LUMBAR VERTEBRAE WAS ABORTED ON THE LEFT SIDE. ABLATION ON THE RIGHT SIDE WAS SUCCESSFUL. THE PHYSICIAN STATED THAT IT IS MORE THAN LIKELY SOME OF THE CURVED CANNULA PEEK SHEARED OFF AND IS STILL IN THE LEFT L5 LUMBAR VERTEBRAL BODY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1431056 INTRACEPT PROBE, RADIOFREQUENCY LESION GXI RELIEVANT MEDSYSTEMS, INC. RLV 0045 35508066 00852454006301

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male