BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROSIGN

    MDR report key: 9768114 · Received February 28, 2020

    Report

    Report Number
    3011755356-2020-00003
    Event Type
    Injury
    Date Received
    February 28, 2020
    Report Date
    January 6, 2020
    Manufacturer
    THE MAGSTIM COMPANY LTD.
    Product Code
    ETN
    PMA / PMN Number
    K181559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MAGSTIM VISITED THE HOSPITAL AND CARRIED OUT A FUNCTIONAL CHECK OF THE NEUROSIGN V4, WHICH WAS PASSED SUCCESSFULLY. IT WAS NOTED THAT THE HOSPITAL WAS OLD AND SOCKETS NEEDED TO BE CHECKED FOR EARTHING. THE CUSTOMER STATED THAT BED-WARMERS AND FANS WERE BEING USED DURING SURGERY. MAGSTIM ADVISED TO TURN THESE DEVICES OFF DURING SURGERY AS THIS COULD CAUSE NOISE TO APPEAR ON THE NEUROSIGN V4. THE CUSTOMER ALSO STATED THAT THE NEUROSIGN V4 IS NOT PLUGGED DIRECTLY INTO THE MAINS SUPPLY, BUT IS USED WITH EXTENSION LEADS. THE CUSTOMER WAS ADVISED TO PLUG IN THE NEUROSIGN V4 INTO THE MAINS SUPPLY DIRECTLY AND NOT USE EXTENSION LEADS. THE INSTRUCTIONS FOR USE FOR THIS DEVICE DESCRIBE THAT 'EQUIPMENT MUST ONLY BE CONNECTED TO AN AC MAINS SUPPLY WITH PROTECTIVE EARTH. CONNECTION SHOULD ONLY BE MADE WITH THE POWER LEAD PROVIDED WITH THE EQUIPMENT'. FURTHER CONTACT WITH THE CUSTOMER WAS STRAINED. MAGSTIM VISITED THE HOSPITAL TO TRAIN THE THEATRE STAFF, HOWEVER WAS ASKED TO LEAVE AS THEY WANTED MAGSTIM TO BE THERE AS 'CLINICAL SUPPORT' INSTEAD OF RECEIVE TRAINING FOR THE STAFF TO OPERATE THE MACHINE THEMSELVES. CONCLUSION: A FUNCTIONAL CHECK OF THE MACHINE CONFIRMED THAT THE DEVICE WORKED AS INTENDED. THE MOST PROBABLE ROOT CAUSE POINTS TOWARDS USER ERROR. THE DEVICE WAS RETURNED TO THE MANUFACTURER (IT WAS A DEMO) AS THE STAFF WAS NOT WILLING TO LEARN AND ACCEPT SUPPORT OTHER THAN MAGSTIM TO DO THE MONITORING FOR THEM DURING SURGICAL PROCEDURES.

    Additional Manufacturer Narrative · 1

    ANOTHER VISIT TO THE CUSTOMER WAS PLANNED TO FURTHER INVESTIGATE. 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

    IT WAS REPORTED THAT THE MACHINE WAS PRODUCING A DISTURBING SOUND DURING USE, EVEN AFTER CHECKING THE IMPEDANCE. THE CUSTOMER ADVISED THAT LAST TIME IT WAS USED FOR A THYROIDECTOMY SURGERY, WHEN THE BIPOLAR STIMULATING PROBE WAS CONNECTED, IT DID NOT WORK (NO SIGNAL OR ANY FUNCTION FROM DEVICE). AFTER THE PROBE WAS REMOVED, THE DEVICE DID NOT WORK ANYMORE. THE SURGERY WAS FURTHER PERFORMED WITHOUT MONITORING. NO REPORTS OF PATIENT/USER OR ANY PERSON HARM WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231642 NEUROSIGN NEUROSIGN V4 ETN THE MAGSTIM COMPANY LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other BIPOLAR STIMULATING PROBE| NEUROSIGN V4 MUTE SENSOR| NEUROSIGN V4 PRE-AMPLIFIER| NEUROSIGN V4 STIMULATOR POD