BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRACEPT FLEXIBLE BI-POLAR RF PROBE

    MDR report key: 8074276 · Received November 15, 2018

    Report

    Report Number
    3006789852-2018-00001
    Event Type
    Injury
    Date Received
    November 15, 2018
    Date of Event
    August 7, 2018
    Report Date
    November 15, 2018
    Manufacturer
    RELIEVANT MEDSYSTEMS INC
    Product Code
    GXI
    UDI-DI
    10852454006124
    PMA / PMN Number
    K170827
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FIRST VB FRACTURE FOLLOWING AN INTRACEPT BASAL VERTEBRAL NERVE ABLATION PROCEDURE THAT WAS NOT DIRECTLY ATTRIBUTABLE TO UNDERLYING PT CONDITION.

    Description of Event or Problem · 1

    (B)(6) MALE PATIENT WITH LONG HISTORY OF LOW BACK PAIN UNDERWENT UNCOMPLICATED L3 AND L4 INTRACEPT PROCEDURE ON (B)(6) 2018 FOR PRESUMED VERTEBROGENIC PAIN. THE PATIENT HAD NO HISTORY OF OSTEOPOROSIS AND THERE WAS NO CLINICAL SUSPICION OF BONE FRAGILITY. PER THE TREATING PHYSICIAN, THE PATIENT FAILED TO IMPROVE POST-PROCEDURE AND HAD SLIGHT WORSENING OF HIS USUAL BASELINE PAIN. PATIENT CONTINUED TO BE ABLE TO PERFORM ADLS, INCLUDING WORKING FULL TIME WITHOUT ANY MEDICATIONS. THE LACK OF IMPROVEMENT LED THE PHYSICIAN TO PERFORM MRI OF THE LUMBOSACRAL SPINE ON (B)(6) 2018, SHOWING NEW L4 SUPERIOR ENDPLATE FRACTURE. THERE WAS NO LOSS OF VERTEBRAL BODY HEIGHT AND NO EVIDENCE OF NEURAL IMPINGEMENT OR SPINAL CANAL COMPROMISE. THE RF ABLATION ZONE DID NOT APPEAR TO OVERLAP WITH THE ENDPLATE. THE PATIENT UNDERWENT UNCOMPLICATED VERTEBRAL KYPHOPLASTY ON (B)(6) 2018 WITH RESOLUTION OF PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914322 INTRACEPT FLEXIBLE BI-POLAR RF PROBE RADIOFREQUENCY LESION PROBE GXI RELIEVANT MEDSYSTEMS INC FG0038 14985-100416 10852454006124

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention INTRACEPT ACCESS INSTRUMENTS