BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROTHERM¿ RF NEEDLE

    MDR report key: 5029445 · Received August 25, 2015

    Report

    Report Number
    3002953813-2015-00015
    Event Type
    Injury
    Date Received
    August 25, 2015
    Date of Event
    March 12, 2015
    Report Date
    July 28, 2015
    Manufacturer
    NEUROTHERM, INC
    Product Code
    GXI
    PMA / PMN Number
    K000706
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE BATCH NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED PATIENT BURN COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, THE USER SHOULD AVOID INSERTING THE RF CANNULA TO THE POINT WHERE THE HUB COMES IN CONTACT WITH THE SKIN DURING THE PROCEDURE.

    Description of Event or Problem · 1

    RELATED TO MW5042453. DURING A BILATERAL DORSAL RAMUS L5 ABLATION PROCEDURE, A PATIENT BURN OCCURRED. THE NEUROTHERM GROUNDING PAD WAS PLACED ON THE RIGHT POSTERIOR THIGH AND THE PROCEDURE WAS COMPLETED USING NEUROTHERM RF NEEDLES. DURING A FOLLOW UP VISIT, TWO BURNS WERE NOTED AT THE SITE OF NEEDLE ENTRY, ONE DIME-SIZED AND THER OTHER 4MM ACROSS. THE BURNS WERE EXCISED AND CLOSED. THE BURNS HAVE SINCE HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559927 NEUROTHERM¿ RF NEEDLE DISPOSABLE RF CANNULA GXI NEUROTHERM, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention