BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRACEPT RF PROBE

    MDR report key: 22377568 · Received July 1, 2025

    Report

    Report Number
    3006630150-2025-05042
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    June 4, 2025
    Report Date
    October 21, 2025
    Manufacturer
    RELIEVANT MEDSYSTEMS, INC.
    Product Code
    GXI
    UDI-DI
    00852454006219
    PMA / PMN Number
    K180369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE RACE FIELD (A6) IN SECTION A, PATIENT INFORMATION, THE OUTCOMES ATTRIBUTED TO ADVERSE EVENT FIELD (B2) IN SECTION B, ADVERSE EVENT/PRODUCT PROBLEM, AND THE IMPACT CODE DESCRIPTION, IMPACT CODE FIELD (H6) IN SECTION H, DEVICE MANUFACTURERS ONLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE, THE PATIENT'S AIRWAY BECAME COMPROMISED AND THE PATIENT NEEDED TO BE FLIPPED BACK SUPINE TO RESTORE THEIR AIRWAY. THE PROCEDURE WAS ABORTED AND RESCHEDULED AT A LATER DATE. THE PATIENT WAS SEDATED WITH GENERAL ANESTHESIA. THE PHYSICIAN ASSESSED THE EVENT AS NOT BEING RELATED TO THE DEVICE OR THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE, THE PATIENT'S AIRWAY BECAME COMPROMISED AND THE PATIENT NEEDED TO BE FLIPPED BACK SUPINE TO RESTORE THEIR AIRWAY. THE PROCEDURE WAS ABORTED AND RESCHEDULED AT A LATER DATE. THE PATIENT WAS SEDATED WITH GENERAL ANESTHESIA. THE PHYSICIAN ASSESSED THE EVENT AS NOT BEING RELATED TO THE DEVICE OR THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LARYNGEAL MASK AIRWAY (LMA) WAS PULLED BACK BECAUSE IT WAS NOT SECURED PROPERLY AND NEEDED TO BE REPOSITIONED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INTERCEPT PROCEDURE, THE PATIENTS AIRWAY BECAME COMPROMISED AND THE PATIENT NEEDED TO BE FLIPPED BACK SUPINE TO RESTORE THEIR AIRWAY. THE PROCEDURE WAS ABORTED AND RESCHEDULED AT A LATER DATE. THE PATIENT WAS SEDATED WITH GENERAL ANESTHESIA. THE PHYSICIAN ASSESSED THE EVENT AS NOT BEING RELATED TO THE DEVICE OR THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LARYNGEAL MASK AIRWAY (LMA) WAS PULLED BACK BECAUSE IT WAS NOT SECURED PROPERLY AND NEEDED TO BE REPOSITIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1313758 INTRACEPT RF PROBE PROBE, RADIOFREQUENCY LESION GXI RELIEVANT MEDSYSTEMS, INC. RLV 0015 36576166 00852454006219

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Life Threatening| R