BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRACEPT

    MDR report key: 22190306 · Received June 11, 2025

    Report

    Report Number
    3006630150-2025-04339
    Event Type
    Malfunction
    Date Received
    June 11, 2025
    Date of Event
    May 13, 2025
    Report Date
    June 11, 2025
    Manufacturer
    RELIEVANT MEDSYSTEMS, INC.
    Product Code
    GXI
    UDI-DI
    00852454006226
    PMA / PMN Number
    K222281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE INTRACEPT PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE THE J-STYLET. THE PHYSICIAN WAS ADVISED TO RE-DOCK AND RE-ADVANCE THE J-STYLET DUE TO POSITIONING. UPON REMOVAL OF THE J-STYLET, THE DISTAL TIP OF THE CURVED CANNULA WAS SHEARED AND BROKEN OFF. IT WAS UNKNOWN IF ANY BROKEN DEVICE FRAGMENTS WERE LEFT INSIDE THE PATIENT AS IT WAS NOT DETECTABLE ON FLUOROSCOPY. NO DEVICES ARE AVAILABLE TO BE RETURNED FOR DEVICE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2201044 INTRACEPT PROBE, RADIOFREQUENCY LESION GXI RELIEVANT MEDSYSTEMS, INC. RLV 0055 36368653 00852454006226

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female