BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAINLESS STEEL ELECTRODE, REUSABLE, 10CM

    MDR report key: 5251650 · Received November 25, 2015

    Report

    Report Number
    3002953813-2015-00022
    Event Type
    Injury
    Date Received
    November 25, 2015
    Report Date
    November 2, 2015
    Manufacturer
    NEUROTHERM, INC
    Product Code
    GXD
    PMA / PMN Number
    K052878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RECEIVED IN THE POSTMARKET SURVEILLANCE LAB FOR ANALYSIS. OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED FACIAL PARESTHESIA WAS PROCEDURE RELATED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FOLLOWING A TRIGEMINAL NERVE ABLATION PROCEDURE, THE PATIENT DEVELOPED RIGHT FACIAL PARESTHESIA. A NEUROTHERM RFE-10 ELECTRODE WAS USED TO PERFORM ABLATION ON THE TRIGEMINAL NERVE. FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED RIGHT OCULAR AND FACIAL PARASTHESIAS, WHICH WERE TEMPORARY, AND THE PATIENT FULLY RECOVERED. IT WAS NOTED THIS MAY HAVE BEEN DUE TO POSITIONING OF THE DEVICE DURING THE PROCEDURE. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH THE ELECTRODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780717 STAINLESS STEEL ELECTRODE, REUSABLE, 10CM PROBE, RADIOFREQUENCY LESION GXD NEUROTHERM, INC RFE-10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other