BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTRACEPT RF PROBE

    MDR report key: 24172278 · Received January 23, 2026

    Report

    Report Number
    3006630150-2026-00495
    Event Type
    Death
    Date Received
    January 23, 2026
    Date of Event
    December 30, 2025
    Report Date
    April 14, 2026
    Manufacturer
    RELIEVANT MEDSYSTEMS, INC.
    Product Code
    GXI
    UDI-DI
    00852454006219
    PMA / PMN Number
    K180369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND THE COMPLAINT AS REPORTED COULD NOT BE CONFIRMED. THERE IS NO REPORTED COMPLAINT AGAINST THE FUNCTIONALITY OF THE DEVICE. THEREFORE, THIS INVESTIGATION IS ASSIGNED A PROBABLE CAUSE OF ADVERSE EVENT RELATED TO PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE, DURING A FIFTEEN MINUTE ABLATION ON THE LAST LEVEL, THE PATIENT BECAME UNSTABLE DUE TO CARDIAC ARREST AND THE PROCEDURE WAS ABORTED WITH ABOUT EIGHT MINUTES LEFT REMAINING ON THE GENERATOR. THE PATIENT WAS ROLLED OVER AND CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED TO REVIVE THE PATIENT. THE PATIENT WAS THEN TRANSPORTED TO THE LOCAL EMERGENCY ROOM (ER). THERE WERE NO REPORTED DEVICE ISSUES DURING THE PROCEDURE AND THE DEVICE WAS DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE, DURING A FIFTEEN MINUTE ABLATION ON THE LAST LEVEL, THE PATIENT BECAME UNSTABLE DUE TO CARDIAC ARREST AND THE PROCEDURE WAS ABORTED WITH ABOUT EIGHT MINUTES LEFT REMAINING ON THE GENERATOR. THE PATIENT WAS ROLLED OVER AND CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED TO REVIVE THE PATIENT. THE PATIENT WAS THEN TRANSPORTED TO THE LOCAL EMERGENCY ROOM (ER). THERE WERE NO REPORTED DEVICE ISSUES DURING THE PROCEDURE AND THE DEVICE WAS DISCARDED BY THE MEDICAL FACILITY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD A PRIOR SCHEDULED INTRACEPT PROCEDURE BUT COULD NOT MAKE THE DATE DUE TO A CARDIAC ISSUE. THE PATIENT PASSED AWAY AFTER ARRIVING AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227879 INTRACEPT RF PROBE PROBE, RADIOFREQUENCY LESION GXI RELIEVANT MEDSYSTEMS, INC. RLV 0015 38002642 00852454006219

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male Death| R| L| H