BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROSIGN

    MDR report key: 11794028 · Received May 7, 2021

    Report

    Report Number
    8021774-2021-00007
    Event Type
    Injury
    Date Received
    May 7, 2021
    Date of Event
    April 5, 2021
    Report Date
    February 17, 2022
    Manufacturer
    THE MAGSTIM COMPANY LIMITED
    Product Code
    ETN
    PMA / PMN Number
    K925056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS RETURNED FOR INVESTIGATION ALONGSIDE DECONTAMINATION CERTIFICATE. DEVICE WAS 17 YEARS OLD, AS CONFIRMED BY REPORTER. INITIAL OBSERVATION OF DEVICE SUGGESTED CASE OF N100 MONITOR HAD BEEN OPENED AS A FIXING SCREW WAS NOT THE STANDARD ISSUE FROM MAGSTIM. DEVICE WAS IN WORKING CONDITION THOUGH FAILED STIM PULSE TEST (TM9883-01 SECTION 4.9 AND 4.10) WHICH IS TO BE EXPECTED FOR A DEVICE OF THIS AGE. IT IS NOT CONSIDERED THE STIM PULSE TO BE ASSOCIATED WITH THE ADVERSE EVENT. AUDIT OF THE DEVICE MANUFACTURE RECORD SHOWED NO DEVIATION TO PROCEDURE. THE DEVICE HISTORY RECORD INDICATED THE DEVICE HAD NOT BEEN RETURNED TO MAGSTIM FOR SERVICING SINCE INITIAL PLACEMENT ON THE MARKET 17 YEARS PRIOR. INVESTIGATION OF THE PRE-AMPLIFIER POD IDENTIFIED A LOOSE SCREW PRESENT IN THE ENCLOSURE. IT IS SUSPECTED THE SCREW HAD THE POTENTIAL TO CAUSE AN INTERMITTENT SHORT CIRCUIT ON THE CIRCUIT BOARD, WHICH MAY HAVE LEAD TO THE INTERMITTENT OPERATING OF CHANNEL 1. A SECOND POTENTIAL SHORT CIRCUIT WAS IDENTIFIED WITH THE 15V INPUT WHICH MAY HAVE LEAD TO A 15MA CURRENT TO BE RELEASED FROM THE ELECTRODE CONNECTION SITE TO THE AMPLIFIER. BOTH SHORT CIRCUIT SCENARIOS WERE NOT CONSIDERED TO HAVE CAUSED THE TEMPERATURE INCREASE REQUIRED TO MELT SOLDER AND CAUSE THE DEFORMATION OF THE ELECTRODE AND NEEDLE, NOR CAUSE THE BURN INJURIES IDENTIFIED IN THIS EVENT. FOLLOW UP INVESTIGATION IDENTIFIED THE DEVICE HAD BEEN DROPPED IN 2017 AND REPAIRED IN-HOUSE BY THE HEALTHCARE FACILITY BY REPLACING THE DAMAGED PARTS. FACILITY ALSO CONFIRMED DEVICE USED BY ONE SURGEON WHO USES IT AS A FREE RUNNING EMG MONITOR WITHOUT THE NEUROSIGN STIMULATING PROBE. FACILITY CONFIRMED THE SURGICAL TEAM USED 3RD PARTY HAND HELD STIMULATING DEVICE DURING THE PROCEDURE. MAGSTIM HAS HAD A NHS SPECIALIST TECHNICIAN WITH 30 YEARS OF NEUROSIGN EXPERIENCE REVIEW THE EVENT AND THESE WERE HIS FINDINGS: "GIVEN THAT THERE IS LIMITED INFORMATION IT IS NOT POSSIBLE TO ABSOLUTELY ATTRIBUTE A CAUSE FOR THE PATIENT INJURIES. ON THE BALANCE OF PROBABILITY, I BELIEVE IT IS MORE LIKELY THAT THE BURNS WERE CAUSED BY ELECTROCAUTERY USE THAN ANY FAULT OF THE NEUROSIGN, BUT THE FACT THAT THERE WAS A TRAPPED SCREW OBVIOUSLY MEANS THAT A FAULT MAY HAVE DEVELOPED WHICH HAS NOT BEEN CONSIDERED BY THE ENGINEERS. FUNDAMENTALLY, ANY FAULT MUST HAVE BEEN ABLE TO PASS SUFFICIENT CURRENT TO GENERATE ENOUGH HEAT TO MELT THE SOLDER JOINT AND TO DAMAGE THE INSULATION. THE ENGINEER HAS PROVED THAT THE NEUROSIGN PREAMPLIFIER CURRENT IS NOT SUFFICIENT TO ACHIEVE THIS, AND THERE- FORE I AM FORCED TO BELIEVE THAT THE INSTRUMENT WHICH IS DESIGNED TO GENERATE HEAT, THE ELECTROCAUTERY MACHINE, IS THE LIKELY CAUSE." DUE THE COMBINATION OF THESE FACTORS IT WAS DETERMINED THAT IT WAS UNLIKELY THAT THE N100 CAUSED THE INJURIES SUFFERED BY THE PATIENT. N100 IS CURRENTLY BEING DISCONTINUED DUE TO MARKETING REASONS. N100 HAS A 5 YEAR DESIGN LIFETIME APPLIED BY MAGSTIM. DEVICE IN QUESTION HAD BEEN IN USE FOR 17 YEARS. RISK ASSESSMENT WAS CONSIDERED ACCEPTABLE FOR THE DEVICE AND NO FURTHER REVIEW WAS REQUIRED.

    Description of Event or Problem · 0

    INITIAL INCIDENT REPORT [FDA REPORT REF (B)(4)] STATED PATIENT SUSTAINED SEVERAL SMALL BURNS (LEFT CHEEK, LEFT TEMPLE, UPPER CHEST) DURING PAROTIDECTOMY DURING WHICH CAUTERY WAS USED. UPON INITIAL REPORT IT WAS UNCLEAR IF BURNS WERE ATTRIBUTABLE TO FACIAL NERVE MONITORING INCIDENT INVESTIGATION REVEALED PATIENT WAS UN-DRAPED (ALLOWING SURGICAL TEAM TO DISCOVER BURNS). SURGICAL TEAM NOTICED SUBDERMAL ELECTRODES AT BURN SITES SHOWED SIGNS OF DEFORMATION. DURING REMOVAL OF THE ELECTRODES, THE LEAD WIRE OF THE LEFT CHEEK DETACHED LEAVING SUBDERMAL NEEDLE IN PATIENT'S CHEEK. INCIDENT REPORTED TO MANUFACTURER FOR INVESTIGATION. DEVICE IN QUESTION IS CURRENTLY BEING DISCONTINUED PRODUCT LINE, IT IS BEING REMOVED FROM THE MARKET DUE TO MARKETING REASONS.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO MAGSTIM ON 04/27/2021 HOWEVER WAS ABSENT A DECONTAMINATION CERTIFICATE. ACCORDING TO THE MAGSTIM QMS, THE INVESTIGATION COULD NOT BEGIN UNTIL THE DECONTAMINATION CERTIFICATE HAD BEEN PROVIDED. THE DECONTAMINATION CERTIFICATE WAS RECEIVED ON 05/06/2021.

    Description of Event or Problem · 1

    INITIAL DESCRIPTION AS PER US FDA FORM 35000A UF REPORT# (B)(4): "FACIAL NERVE MONITORING PERFORMED DURING LEFT PAROTIDECTOMY IN WHICH CAUTERY WAS UTILIZED. POST-SURGERY, IT WAS DISCOVERED THAT THE PATIENT HAD SUSTAINED X3 SMALL BURNS (L CHEEK, L TEMPLE, UPPER CHEST)." FURTHER INVESTIGATION HAS CONFIRMED THAT: INCIDENT: THE INCIDENT WAS CONFIRMED WHEN THE PATIENT WAS UN-DRAPED, WHERE THE SURGICAL TEAM NOTICED THE BURNS AT THE SITE OF ELECTRODE PLACEMENT (L CHEEK, L TEMPLE, UPPER CHEST). THE SURGICAL TEAM NOTICED THE SUB-DERMAL ELECTRODES AT THE SITES WHERE BURNING OCCURRED HAD DEFORMED. DURING REMOVAL, THE LEAD WIRE OF THE L CHEEK SUBDERMAL ELECTRODE DETACHED FROM THE NEEDLE DUE TO THE DEFORMATION LEAVING THE SUBDERMAL NEEDLE IN THE PATIENTS L CHEEK. A SECOND ELECTRODE SHOWED SIMILAR SIGNS OF DEFORMITY; HOWEVER, THIS WAS SUCCESSFULLY RETRACTED FROM THE PATIENT. PATIENT HARM: THE PATIENT SUSTAINED LOCALISED BURNING TO THE L CHEEK AND L TEMPLE, AS WELL AS THE UPPER CHEST, DUE TO THE DEFORMING OF THE SUBDERMAL ELECTRODE, THE NEEDLE WAS NOT DETRACTED. POST-SURGERY IN RECOVERY, THE PATIENT HAS COMPLAINED OF LOSS OF SENSATION IN THE CHEEK, RAISING CONCERNS REGARDING NERVE DAMAGE. THE PATIENT HAS BEEN REFERRED TO THE PLASTICS DEPARTMENT TO REMOVE THE REMAINING FOREIGN OBJECT (SUBDERMAL NEEDLE) AND ATTEND TO THE FACIAL BURNS. THERE IS NO CURRENT INDICATION AS TO WHAT FURTHER TREATMENT IS BEING GIVEN FOR THE POTENTIAL NERVE DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688607 NEUROSIGN NEUROSIGN 100 ETN THE MAGSTIM COMPANY LIMITED 9883-01

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Disability| R| O