BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROSIGN

    MDR report key: 3650383 · Received January 24, 2014

    Report

    Report Number
    8021774-2013-00001
    Event Type
    Injury
    Date Received
    January 24, 2014
    Date of Event
    December 5, 2013
    Report Date
    January 17, 2013
    Manufacturer
    THE MAGSTIM COMPANY LTD.
    Product Code
    ETN
    PMA / PMN Number
    K923056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAGSTIM WAS INITIALLY CONTACTED BY (B)(6) ON THE (B)(6) 2013, WHERE HE REQUESTED AN EVALUATION OF A NEUROSIGN 100. AT THIS TIME, THERE WAS NO MENTION OF AN ADVERSE EVENT. MAGSTIM WAS FIRST INFORMED OF THE ADVERSE EVENT ON RECEIPT OF (B)(4) ON THE 01/07/2014. THE DEVICE WAS RECEIVED FOR REPAIR BY MAGSTIM ON 01/09/2013. THE NEUROSIGN 100 AND ALL ACCESSORIES WERE TESTED AND WERE OPERATING NORMALLY. IT WAS NOTICED DURING INSPECTION THAT THERE WAS DAMAGE TO THE PRE-AMP INPUT CONNECTOR ON THE REAR PANEL (EEG NEEDLE ELECTRODES ARE CONNECTED TO THIS ACCESSORY). DAMAGE TO THIS INPUT CONNECTOR COULD LEAD TO AN INTERMITTENT OR NO CONNECTION WITH THE NEUROSIGN 100 UNIT RESULTING IN NO RESPONSE FROM THE VOLUME AND BAR. FURTHER DETAILS OF THE TESTING WILL BE PROVIDED UPON REQUEST. THERE ARE A NUMBER OF PRE-USE CHECKS THAT MAGSTIM INFORMS THE USER TO PERFORM PRIOR TO USE OF THE MONITOR WHICH INCLUDES CHECKING THE AMPLIFIERS AND CHECKING FOR ANY SIGNS OF DAMAGE. FROM THE DAMAGE OBSERVED TO THE INPUT CONNECTOR, IT APPEARS THAT THIS PROCESS WAS NOT FOLLOWED IN THIS CASE. FROM THE EVIDENCE OBTAINED DETAILED ABOVE, IT IS REASONABLE TO CONCLUDE THAT THE ADVERSE EVENT DATED THE 12/05/2013, WAS NOT CAUSED BY THE NEUROSIGN 100, BUT AS A RESULT OF USER ERROR.

    Description of Event or Problem · 1

    INITIAL REPORT (B)(4) RECEIVED BY MAGSTIM 01/07/2014. EVENT DESCRIPTION: PATIENT WAS HAVING A TYMPANOMASTOIDECTOMY AND NEUROSIGN FACIAL NERVE MONITOR WAS PLACED ON LEFT FACE PRIOR TO DRAPING. VOLUME ALARM AND BAR WERE SET. DURING CASE, NO ALARM NOR CHANGE IN BAR WERE NOTED. CASE ENDED UNEVENTFULLY, AND PATIENT WENT TO PACU. DOCTOR LET ME KNOW THAT THERE WAS ISSUES WITH THE FACIAL NERVE AND HE BEGAN TREATMENT. I REMOVED THE NEUROSIGN FROM SERVICE AND CONTACTED BIOMED TO COME EVALUATE IT. PMM'S LAST PERFORMED APPROXIMATELY 2 WEEKS PRIOR TO EVENT. WHAT WAS THE ORIGINAL INTENDED PROCEDURE. LEFT TYMPANOMASTOIDECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56022 NEUROSIGN NEUROSIGN 100, 874.1820 ETN THE MAGSTIM COMPANY LTD. 9883-01

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention