BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROSIGN

    MDR report key: 9705519 · Received February 13, 2020

    Report

    Report Number
    3011755356-2020-00002
    Event Type
    Malfunction
    Date Received
    February 13, 2020
    Date of Event
    January 14, 2020
    Report Date
    January 17, 2020
    Manufacturer
    THE MAGSTIM COMPANY LIMITED
    Product Code
    ETN
    PMA / PMN Number
    K923056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO MAGSTIM FOR INVESTIGATION. DURING THE INVESTIGATION, WHEN INCREASING (CLOCKWISE) THE CURRENT POTENTIOMETER ON THE N100 TO 5MA (4.9), THE STIMULATOR PULSE WAS SEEN TO FLUCTUATE. REDUCING (ANTI-CLOCKWISE) THE CURRENT POTENTIOMETER VERY SLIGHTLY CAUSED A BIG DECREASE IN THE AMPLITUDE OF THE STIMULATOR PULSE. IT IS A CHARACTERISTIC OF THE STIMULATOR PULSE IN A N100 TO FLUCTUATE SLIGHTLY, HOWEVER WHEN THE DECREASE IN AMPLITUDE IS TO THE AMOUNT OBSERVED, THIS INDICATES THAT THE CURRENT POTENTIOMETER IS FAULTY. SHOULD THE SURGEON BE USING THE N100 AT MAXIMUM CURRENT (5MA), IT IS LIKELY THAT THEY EXPERIENCED THIS FLUCTUATION IN STIMULATOR PULSE AMPLITUDE, CAUSING THE INTERMITTENT RESPONSE DURING STIMULATION. PROBABLE ROOT CAUSE - FAULTY CURRENT POTENTIOMETER (P/N475048), WHILST THE DEVICE HAD EXCEEDED ITS LIFETIME.

    Additional Manufacturer Narrative · 1

    MAGSTIM'S PRODUCT/CLINICAL SPECIALIST CONTACTED THE HOSPITAL ON THE ISSUE. FEEDBACK RECEIVED FROM THE THEATRE MANAGER SUGGESTED THAT USER ERROR CAUSED THE ISSUE. IT APPEARS THAT WHEN THE DEVICE IS USED WHEN A REPRESENTATIVE OF MAGSTIM IS PRESENT THAT NO ISSUES ARE REPORTED. MAGSTIM'S PRODUCT/CLINICAL SPECIALIST ADVISED THE THEATRE MANAGER THAT, BECAUSE OF THE FACT THAT THE MACHINE DID NOT ALARM WHEN STIMULATED, AND THE POST-OPERATIVE ASSESSMENT CONFIRMED NO INJURY, THE MACHINE PROBABLY WORKED AS INTENDED I.E. IF IT WAS THE NERVE THAT WAS STIMULATED, THE MACHINE WOULD HAVE ALARMED. ALTHOUGH MAGSTIM'S PRODUCT/CLINICAL SPECIALIST CONTACTED THE HOSPITAL FOR ADVICE, THE HOSPITAL DID NOT WANT A VISIT BY MAGSTIM FOR TRAINING OR ADVICE AND INSTEAD DECIDED TO DISCARD THE PRODUCT'S USE. THE MAGSTIM COMPANY LTD. IS, AS PER YOUR REQUEST, CURRENTLY IN THE PROCESS OF SETTING UP A WEBTRADER ACCOUNT FOR MAGSTIM INC. USA. DURING THIS TRANSITION TIME, PLEASE ACCEPT THIS SUBMISSION AS OF THE MAGSTIM COMPANY LTD. AND MAGSTIM INC. USA BOTH. EXEMPTION NUMBER E2018009. (B)(4).

    Description of Event or Problem · 1

    THYROID SURGERY. SURGEON ADVISED THAT WHEN STIMULATING THE RESPONSE WAS INTERMITTENT. SURGEON ALSO ADVISED THAT HE WAS STIMULATING THE RECURRENT LARYNGEAL NERVE (RLN) AND THERE WAS NO RESPONSE PROVIDED BY THE NERVE MONITOR. SURGEON THEN ALARMED THE THEATRE MANAGER THAT HE HAD CUT THE RLN AND APPEARED WORRIED ABOUT PERMANENT DAMAGE. POST-SURGERY ASSESSMENT ON THE PATIENT CONFIRMED THAT THERE WAS NO DAMAGE CAUSED TO THE NERVE AND PATIENT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171266 NEUROSIGN NEUROSIGN 100 ETN THE MAGSTIM COMPANY LIMITED 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other BIPOLAR PROBE 3601-00| LANTERN LARYNGEAL ELECTRODE (LLE) 6/7 MM