BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROSIGN

    MDR report key: 11904474 · Received May 28, 2021

    Report

    Report Number
    8021774-2021-00008
    Event Type
    Injury
    Date Received
    May 28, 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

    A CALL WAS MADE WITH INITIAL REPORTER AND HIS TEAM, AND IT WAS DISCOVERED THE DEVICE WAS DROPPED IN 2017 AND THE HOSPITAL REPAIRED THE DEVICE THEMSELVES BY OPENING THE DEVICE AND REPLACING THE BROKEN ENCLOSURE. THEY ALSO STATED THAT THE SURGEON ONLY USES THE DEVICE SOLELY AS A FREE RUNNING EMG MONITOR WITHOUT THE USE OF STIMULATING PROBE. ONCE THE DEVICE WAS RECEIVED BACK BY MAGSTIM AND A DECONTAMINATION CERTIFICATE WAS ACQUIRED AN INVESTIGATION OF THE DEVICE WAS INITIATED. INITIAL OBSERVATIONS SUGGESTED THAT THE ENCLOSURE OF THE N100 MONITOR HAD BEEN OPENED AS ONE OF THE FIXING SCREWS WAS NOT STANDARD ISSUE. THE N100 WAS IN WORKING CONDITION BUT IT DID FAIL THE STIM PULSE TEST (TM9883-01, SECTION 4.9 AND 4.10) WHEN TESTED, THIS IS NOT UNUSUAL FOR AN N100 OF THIS AGE AND IS NOT ASSOCIATED WITH A FAILURE TO CAUSE THIS KIND OF HEALTH IMPACT. DURING INVESTIGATION OF THE NEUROSIGN 100 PRE-AMPLIFIER POD, WHEN REMOVING THE PRINTED CIRCUIT BOARD A LOOSE SCREW WAS PRESENT INSIDE THE ENCLOSURE. IT IS POSSIBLE THAT THE LOOSE SCREW HAD THE POTENTIAL TO CAUSE AN INTERMITTENT SHORT CIRCUIT AT VARIOUS LOCATIONS OF THE CIRCUIT, ONE OF WHICH POTENTIALLY CAUSING CHANNEL 1 TO OPERATE INTERMITTENTLY. IT WAS ALSO MENTIONED BY THE CUSTOMER THAT A MEMBER OF THE SURGICAL TEAM NOTED THAT IN THEY NOTICED THAT THE DEVICE WAS NOT WORKING BUT CONTINUED TO USE THE DEVICE FOR THE SURGERY WITHOUT QUESTIONING OR INVESTIGATING AND THE SURGEON DECIDED TO CARRY ON KNOWING THE N100 WAS NOT FUNCTIONING CORRECTLY. 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 EFFECTS 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. THE DEVICE SUBJECT TO THIS REPORT, IS ALSO THE DEVICE SUBJECT TO REPORT #8021774-2021-00007.

    Description of Event or Problem · 0

    THE FOLLOWING DESCRIPTION OF EVENT WAS PROVIDED BY THE INITIAL REPORTER VIA MEDWATCH FORM FDA 3500A "PT HAD NERVE INADVERTENTLY SEVERED DURING THYROIDECTOMY. STAFF DO NOT RECALL HEARING NERVE MONITOR SOUND AN ALARM DURING PROCEDURE."

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO MAGSTIM ON 04/27/2021, AND THE INVESTIGATION IS ONGOING. ONCE THE INVESTIGATION HAS BEEN COMPLETED, THE CONCLUSION OF THE INVESTIGATION WILL BE SUBMITTED TO THE US FDA IN EITHER A FOLLOW-UP REPORT, OR A FINAL REPORT. THE DEVICE SUBJECT TO THIS REPORT, IS ALSO THE DEVICE SUBJECT TO REPORT #8021774-2021-00007.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF EVENT WAS PROVIDED BY THE INITIAL REPORTER VIA MEDWATCH FORM FDA 3500A "PT HAD NERVE INADVERTENTLY SEVERED DURING THYROIDECTOMY. STAFF DO NOT RECALL HEARING NERVE MONITOR SOUND AN ALARM DURING PROCEDURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798820 NEUROSIGN NEUROSIGN 100 ETN THE MAGSTIM COMPANY LIMITED 9883-01

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Female Disability| O