BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTRACEPT RF PROBE

    MDR report key: 21656127 · Received March 20, 2025

    Report

    Report Number
    3006630150-2025-01664
    Event Type
    Death
    Date Received
    March 20, 2025
    Date of Event
    February 21, 2025
    Report Date
    July 11, 2025
    Manufacturer
    RELIEVANT MEDSYSTEMS, INC.
    Product Code
    GXI
    UDI-DI
    00852454006219
    PMA / PMN Number
    K180369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO INITIAL EMDR IN BLOCK D4.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INTRACEPT PROCEDURE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. HOWEVER, THE PATIENT HAD AN ISSUE WITH THE ANESTHESIA. THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM (ER) POST-PROCEDURE. THE PATIENT PASSED AWAY AFTER SOME ANESTHESIA CHALLENGES POST-PROCEDURE. THE PHYSICIAN ACKNOWLEDGED THAT THE PATIENTS DEATH WAS NOT A PROCEDURE OR DEVICE-RELATED COMPLICATION. NO DEVICES WILL BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INTRACEPT PROCEDURE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. HOWEVER, THE PATIENT HAD AN ISSUE WITH THE ANESTHESIA. THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM (ER) POST-PROCEDURE. THE PATIENT PASSED AWAY AFTER SOME ANESTHESIA CHALLENGES POST-PROCEDURE. THE PHYSICIAN ACKNOWLEDGED THAT THE PATIENTS DEATH WAS NOT A PROCEDURE OR DEVICE-RELATED COMPLICATION. NO DEVICES WILL BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INTRACEPT PROCEDURE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. HOWEVER, THE PATIENT HAD AN ISSUE WITH THE ANESTHESIA. THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM (ER) POST-PROCEDURE. THE PATIENT PASSED AWAY AFTER SOME ANESTHESIA CHALLENGES POST-PROCEDURE. THE PHYSICIAN ACKNOWLEDGED THAT THE PATIENT'S DEATH WAS NOT A PROCEDURE OR DEVICE-RELATED COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537907 INTRACEPT RF PROBE PROBE, RADIOFREQUENCY LESION GXI RELIEVANT MEDSYSTEMS, INC. RLV 0015 108652653 00852454006219

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Death