BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRACEPT

    MDR report key: 23305640 · Received October 15, 2025

    Report

    Report Number
    3006630150-2025-09019
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    August 29, 2025
    Report Date
    October 15, 2025
    Manufacturer
    RELIEVANT MEDSYSTEMS, INC.
    Product Code
    GXI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER AN INTRACEPT PROCEDURE, THE PATIENT EXPERIENCED A LOT OF BLEEDING AND COULD NOT WALK FOR A WEEK. THE PATIENT STATED THAT THE PHYSICIAN WAS UNRESPONSIVE WHEN THEY TRIED TO CONTACT THEM REGARDING THEIR POSTOPERATIVE SYMPTOMS. THE PATIENT ENDED UP GOING TO THE EMERGENCY ROOM (ER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2736949 INTRACEPT PROBE, RADIOFREQUENCY LESION GXI RELIEVANT MEDSYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention