BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRACEPT

    MDR report key: 25017890 · Received April 28, 2026

    Report

    Report Number
    3006630150-2026-02706
    Event Type
    Malfunction
    Date Received
    April 28, 2026
    Date of Event
    September 25, 2025
    Report Date
    April 28, 2026
    Manufacturer
    RELIEVANT MEDSYSTEMS, INC.
    Product Code
    GXI
    UDI-DI
    00852454006301
    PMA / PMN Number
    K222281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EMDR WAS SUBMITTED AS THE REGULATORY ASSESSMENT DECISION FOR THIS COMPLAINT WAS CORRECTED DUE TO A REMEDIATION EFFORT ASSOCIATED WITH (B)(4). THE DEVICE WAS NOT RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS AND THE COMPLAINT AS REPORTED WAS NOT ABLE TO BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET SPECIFICATIONS PRIOR TO SHIPPING. NO MANUFACTURING DEVIATIONS WERE NOTED THAT COULD HAVE CONTRIBUTED TO THE EVENT REPORTED. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF CAUSE NOT ESTABLISHED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE OUTER PACKAGING OF THIS ACCESS ACCESSORY KIT WAS OPENED BY A SCRUB TECH. VISUAL EXAMINATION NOTED A HAIR WITHIN THE STERILE PACKAGING. A NEW KIT WAS OPENED TO COMPLETE THE PROCEDURE. THIS KIT AND ITS PACKAGING WERE DISCARDED AND WERE NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93204 INTRACEPT PROBE, RADIOFREQUENCY LESION GXI RELIEVANT MEDSYSTEMS, INC. RLV 0045 35406853 00852454006301

    Patients

    Seq Age Sex Outcome Treatment
    1