BEUDAMED
    FDA Adverse Event Summary report: N

    NEUROTHERM

    MDR report key: 3161631 · Received May 30, 2013

    Report

    Report Number
    MW5030481
    Date Received
    May 30, 2013
    Date of Event
    March 19, 2013
    Report Date
    May 30, 2013
    Manufacturer
    NEUROTHERM, INC.
    Product Code
    GXD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    POST RADIO-FREQUENCY ABLATION (T10-L1 PERIPHERAL NERVE DESTRUCTION); WHEN THE GROUNDING PAD WAS REMOVED, THE END OF THE CORD WAS HOT NEXT TO THE GROUNDING PAD. WHERE THE CORD/GROUNDING PAD CONTACTED HER SKIN AT THE RIGHT HIP, A REDDENED AREA WITH A BLISTER IN THE CENTER WAS OBSERVED. TREATMENT WAS IMMEDIATELY PROVIDED TO THE PT. THE AREA REQUIRED SEVERAL TREATMENTS/OUTPATIENT, VISITS ((B)(6) 2013) THROUGH THE WOUND CARE DEPARTMENT. EQUIPMENT INVOLVED WAS A GROUNDING PAD, RADIO FREQUENCY, AND A CORD TO CONNECT BETWEEN THE GROUND PAD AND THE RF MACHINE. EQUIPMENT AND DEVICES WERE SENT TO THE OEM MANUFACTURER ON (B)(6) 2013. NEUROTHERM GROUNDING PAD; DISPOSABLE, PART # (B)(4); LOT#E992; EXPIRATION DATE OF 05/01/2014 - MODEL: NEURO THERM NT 2000 RF GENERATOR. SERIAL #(B)(4). GROUNDING PAD CABLE: REUSABLE INDEPENDENT DISPERSIVE CABLE; LOT#01001; PART# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237749 NEUROTHERM GROUNDING PAD REUSABLE DISPENSIVE CABLE GXD NEUROTHERM, INC. 01001
    237750 NEUROTHERM NT 2000 RF GENERATOR GENERATOR GXD NEUROTHERM, INC. NT 2000
    237962 NEUROTHERM GROUNDING PAD GROUNDING PAD GXD NEUROTHERM, INC. E992

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention