BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTRACEPT RF PROBE

    MDR report key: 22822313 · Received August 15, 2025

    Report

    Report Number
    3006630150-2025-06507
    Event Type
    Death
    Date Received
    August 15, 2025
    Date of Event
    July 23, 2025
    Report Date
    August 15, 2025
    Manufacturer
    RELIEVANT MEDSYSTEMS, INC.
    Product Code
    GXI
    UDI-DI
    00852454006219
    PMA / PMN Number
    K180369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INTRACEPT PROCEDURE AND A FIFTEEN MINUTE ABLATION WAS PERFORMED WITHOUT COMPLICATION. HOWEVER, WHEN A SECOND ABLATION WAS INITIATED, THE ANESTHESIA TEAM IDENTIFIED COMPLICATIONS AND REQUESTED THE PROCEDURE BE STOPPED. THE ABLATION WAS IMMEDIATELY HALTED AND THE ANESTHESIA TEAM INITIATED RESUSCITATIVE EFFORTS. THE EMERGENCY MEDICAL SERVICES (EMS) ARRIVED AND TRANSPORTED THE PATIENT TO THE HOSPITAL. THE HOSPITAL CALLED TIME OF DEATH UPON THE PATIENT'S ARRIVAL. THE PHYSICIAN ASSESSED THAT NEITHER THE DEVICE NOR THE PROCEDURE CONTRIBUTED TO THE PATIENT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1559188 INTRACEPT RF PROBE PROBE, RADIOFREQUENCY LESION GXI RELIEVANT MEDSYSTEMS, INC. RLV 0015 35980292 00852454006219

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Death