BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROTHERM¿ RF NEEDLE

    MDR report key: 5029400 · Received August 25, 2015

    Report

    Report Number
    3002953813-2015-00016
    Event Type
    Injury
    Date Received
    August 25, 2015
    Date of Event
    April 27, 2015
    Report Date
    July 28, 2015
    Manufacturer
    NEUROTHERM, INC
    Product Code
    GXI
    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 RIGHT LUMBAR ABLATION PROCEDURE, A PATIENT BURN OCCURRED. A NEUROTHERM GROUNDING PAD WAS PLACED ON THE LEFT POSTERIOR THIGH AND THE PROCEDURE WAS COMPLETED USING NEUROTHERM RF NEEDLES. ABLATION WAS PERFORMED AT TWO SEPARATE SITES WITH LESION TIME OF 2 MINUTES 30 SECONDS AT EACH SITE. ON FOLLOW UP, TWO BURNS WERE NOTED AT THE NEEDLE INSERTION SITES, ONE DIME-SIZED AND ONE 4MM IN DIAMETER. THE BURN WAS EXCISED AND PACKED WITH AQUACEL UNTIL HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559902 NEUROTHERM¿ RF NEEDLE DISPOSABLE RF CANNULA GXI NEUROTHERM, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention