BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRACEPT

    MDR report key: 23586226 · Received November 18, 2025

    Report

    Report Number
    3006630150-2025-10536
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    October 21, 2025
    Report Date
    January 9, 2026
    Manufacturer
    RELIEVANT MEDSYSTEMS, INC.
    Product Code
    GXI
    UDI-DI
    00852454006226
    PMA / PMN Number
    K222281
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CURVED CANNULA, J-STYLET, BEVEL STYLET, AND INTRODUCER CANNULA WERE RETURNED AND ANALYZED. A VISUAL INSPECTION REVEALED THAT THE CURVED CANNULA SHAFT TIP WAS BROKEN. THE BREAKAGE OF THE TIP WAS LIKELY DUE TO USE OF EXCESSIVE FORCE DURING THE PROCEDURE. THE J-STYLET WAS TESTED WITH A KNOWN GOOD CURVED CANNULA AND A KNOWN GOOD INTRODUCER CANNULA TO CONFIRM THAT IT LACKS ANY EXTREME RESISTANCE AND LOCKED DURING THE FUNCTIONAL TEST. THE BEVEL STYLET WAS TESTED WITH A KNOWN GOOD INTRODUCER CANNULA TO CONFIRM THAT IT LACKS ANY EXTREME RESISTANCE AND LOCKED DURING THE FUNCTIONAL TEST. THE INTRODUCER CANNULA WAS ALSO TESTED WITH A KNOWN GOOD BEVEL STYLET TO CONFIRM THAT IT LACKS ANY EXTREME RESISTANCE AND LOCKED DURING THE FUNCTIONAL TEST. A LABELING REVIEW DID NOT REVEAL ANY ANOMALIES AS IT STATES THAT AS WITH ANY SURGICAL INSTRUMENT, CAREFUL ATTENTION MUST BE EXERCISED TO ENSURE THAT EXCESSIVE FORCE IS NOT PLACED ON THE INSTRUMENTS OR PROBE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INTRACEPT PROCEDURE WHERE UPON THE PHYSICIANS FIRST FEW TAPS OF THE MALLET, THE J-STYLET SHARPLY DOVE INFERIORLY. UPON RETRACTING THE J-STYLET AND REMOVAL FROM THE STRAIGHT CANNULA, THE PHYSICIAN NOTICED THAT A PIECE OF THE PEEK SHEATH HAD BEEN SHEARED OFF AND LIKELY REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS ABORTED FOR FURTHER EVALUATION OF THE PATIENT. THE PATIENT WAS THEN WOKEN UP AFTER THE PROCEDURE AND EXPERIENCED RADICULAR PAIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND HAD A MAGNETIC RESONANCE IMAGING (MRI) AND A COMPUTER TOMOGRAPHY (CT) SCAN PERFORMED. THE PATIENTS PAIN SEVERITY REMAINED HIGH. THE PHYSICIAN BELIEVES THAT THE CURVED CANNULA PEEK SHEATH IS IN THE SPINAL CANAL. THE PHYSICIAN REPORTED THAT THE NEUROSURGEON DECOMPRESSED THE NERVE WITH A LAMINECTOMY. THE PHYSICIAN VISUALIZED THE BREACH, BUT DID NOT FIND ANY SHEARED PEEK DEVICE FRAGMENTS, ONLY SOME BONE FRAGMENTS. THE PATIENT STATED THAT THEY WERE EXPERIENCING LESS PAIN AND THAT HER HIP PAIN IMPROVED. THE PATIENT ALSO REPORTED MOSTLY HAVING BACK PAIN. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND THEIR LEG PAIN IS GONE, HOWEVER, THE PATIENT CONTINUES TO HAVE LOW BACK PAIN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INTRACEPT PROCEDURE WHERE UPON THE PHYSICIANS FIRST FEW TAPS OF THE MALLET, THE J-STYLET SHARPLY DOVE INFERIORLY. UPON RETRACTING THE J-STYLET AND REMOVAL FROM THE STRAIGHT CANNULA, THE PHYSICIAN NOTICED THAT A PIECE OF THE PEEK SHEATH HAD BEEN SHEARED OFF AND LIKELY REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS ABORTED FOR FURTHER EVALUATION OF THE PATIENT. THE PATIENT WAS THEN WOKEN UP AFTER THE PROCEDURE AND EXPERIENCED RADICULAR PAIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND HAD A MAGNETIC RESONANCE IMAGING (MRI) AND A COMPUTER TOMOGRAPHY (CT) SCAN PERFORMED. THE PATIENTS PAIN SEVERITY REMAINED HIGH. THE PHYSICIAN BELIEVES THAT THE CURVED CANNULA PEEK SHEATH IS IN THE SPINAL CANAL. THE PHYSICIAN REPORTED THAT THE NEUROSURGEON DECOMPRESSED THE NERVE WITH A LAMINECTOMY. THE PHYSICIAN VISUALIZED THE BREACH, BUT DID NOT FIND ANY SHEARED PEEK DEVICE FRAGMENTS, ONLY SOME BONE FRAGMENTS. THE PATIENT STATED THAT THEY WERE EXPERIENCING LESS PAIN AND THAT HER HIP PAIN IMPROVED. THE PATIENT ALSO REPORTED MOSTLY HAVING BACK PAIN. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND THEIR LEG PAIN IS GONE, HOWEVER, THE PATIENT CONTINUES TO HAVE LOW BACK PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237127 INTRACEPT PROBE, RADIOFREQUENCY LESION GXI RELIEVANT MEDSYSTEMS, INC. RLV 0055 36315014 00852454006226

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Hospitalization| R