BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROTHERM DISPOSABLE GROUNDING PAD

    MDR report key: 3980271 · Received June 5, 2014

    Report

    Report Number
    3002953813-2014-00002
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 9, 2014
    Manufacturer
    NEUROTHERM, INC.
    Product Code
    GXD
    PMA / PMN Number
    K052878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE GROUNDING POT UNDERWENT VISUAL, PERFORMANCE AND MECHANICAL/PHYSICAL TESTING UPON RETURN ((B)(4) 2014). IT WAS TESTED USING THREE STANDARD 10 CM TEST PROBES. EACH TEST PROBE WAS INSERTED INTO A 10CM SMK CANNULA. AS EACH PROBE WAS PLACED INSIDE THE GROUNDING PAD HIGH IMPEDANCE WAS PRESENT. EACH CHANNEL DISPLAYED AN IMPEDANCE OF BETWEEN 800 AND 1000 OHMS. ALL THREE CHANNELS DISPLAYED TEMPERATURE. A THREE LESION PROCEDURE AT 90C FOR ONE MINUTE WAS ATTEMPTED THREE TIMES. ATTEMPT 1: INTERLOCK ERROR MESSAGE. ATTEMPT 2: SEVERE TEMPERATURE FLUCTUATIONS THROUGHOUT PROCEDURE BUT NO ERROR MESSAGE. ATTEMPT 3: INTERLOCK ERROR MESSAGE. THE PAD WAS ALSO TESTED WITH AN ELECTRODE BEING PLACED DIRECTLY INTO THE GROUNDING PAD WITH NO CANNULA. IMPEDANCE READINGS WERE NORMAL (250 TO 350 OHMS). A ONE MINUTE LESION WAS RUN AT 90C AND FUNCTIONED AS INTENDED. THE GENERATOR USED IN THIS PROCEDURE HAS NOT YET BEEN RETURNED BUT HAS BEEN REQUESTED IN ORDER TO INVESTIGATE THE CSV FILES FOR ABNORMALITIES. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2014, PROBES WERE INSERTED INTO THE THREE SMK NEEDLES ON ONE SIDE OF THE PT AND LESION WAS CHOSEN. ONLY ONE PROBE REACHED TEMPERATURE. THE PROBES WERE REPOSITIONED ON THE OTHER SIDE OF THE PT. THE MESSAGE ASKING TO CONTINUE THE PROCEDURE USING ONE PROBE CAME UP AGAIN. THE RF MACHINE WAS THEN REBOOTED. AGAIN BUT THE SAME MESSAGE APPEARED ASKING TO CONTINUE THE PROCEDURE USING ONE PROBE. THE PROCEDURE WAS ABORTED AT THIS TIME. UPON REMOVAL OF THE GROUNDING PAD (WHICH HAD BEEN PLACED ON THE PT AND PLUGGED IN SINCE THE START OF THE PROCEDURE), THERE WAS A SMALL AREA OF REDDENING OF THE PT'S SKIN ALONG WITH A LIGHT THIN BLISTER ROUGHLY 1 TO 1.5 INCHES IN LENGTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329878 NEUROTHERM DISPOSABLE GROUNDING PAD DISPOSABLE GROUNDING PAD GXD NEUROTHERM, INC. RF-DGP-S 20131120

    Patients

    Seq Age Sex Outcome Treatment
    1 Other