MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM® EMG - ENDOTRACHEAL TUBE; STIMULATOR, NERVE

Model Number	8229308
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The surgeon reported that once the patient was positioned with a shoulder roll during a thyroidectomy, laryngoscopy was used to confirm that the endotracheal tube was positioned correctly.An electrode check was performed on the nim monitor; at first, vocalis 1 had a red x, but then it turned to a green check mark.Everything else had green checkmarks, and all of the impedances were within normal limits.The right recurrent laryngeal nerve (rln) was encased in an aggressive tumor; the difficult dissection may have caused neuropraxia, and that is why the right rln never responded to stimulation.That nerve was sacrificed due to the large, invasive cancer on that side.The left thyroid lobe and left recurrent laryngeal nerve appeared normal, and the dissection was routine; however, the left recurrent laryngeal nerve never stimulated (responded) at any point during the case, even though the nim system was providing the expected audible feedback that indicated that stimulus was being delivered.No error message displayed on monitor at any time.The stimulus was delivered using a range of 0.8 to 1.2 ma, and the threshold was set to the default setting.At the completion of the case, another electrical check was performed; at this time vocalis 1 alternated between a red x and a green check mark several times.The patient was scoped after extubation, and their left vocal fold was moving normally, indicating that the left rln was intact.There was no patient injury due to the reported issue.
Additional Manufacturer Narrative
H3: analysis found visually, there were biological contaminants on the distal end of the device and tape was adhered to the proximal end of the device.Electrically, resistance of each lead shall be between 1.7 and 3.7 ohms and the actual measurements were 3.4 ohms (blue), 3.7 ohms (blue with clear tubing), 3.6 ohms (red), and 3.3 ohms (red with clear tubing) which all the electrodes were in specification.Functionally, for further analysis, the device was connected to a nim system, and the device passed the electrode check and had no erratic behavior during functional testing.There was no intermittent behavior while manipulating the connections or the shape of the device.For additional analysis, a syringe was used to inject 20cc of air into the cuff balloon and there were no issues during inflation or deflation.A review of the global complaint data showed no other complaints about this lot number.H6: previous codes fdm- b21, fdc- c21 and fdr- d16 are no longer applicable.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NIM® EMG - ENDOTRACHEAL TUBE
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: glen belmer ; 6743 southpoint drive north; jacksonville, FL 32216 ; 6122713209
• MDR Report Key: 16111605
• Report Number: 1045254-2023-00022
• Device Sequence Number: 17859411
• Product Code: ETN
• UDI-Device Identifier: 00643169789548
• UDI-Public: 00643169789548
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K925640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/16/2026
• Device Model Number: 8229308
• Device Catalogue Number: 8229308
• Device Lot Number: 0224898228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2022
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 77 KG