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

Model Number	8229708
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	08/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) reported that the tube was not sensing the left vocalis and the patient had to be re-intubated during the procedure.The green checkmark on the et tube did not light up, indicating that the vocalis was not being sensed properly.There was nothing causing a lack of response from the et tube.The case was completed as planned after the et tube was replaced.The patient was under general anesthesia.There was a delay in the procedure as they have to re-intubate the patient; however, this did not affect his overall care.The mainframe as a whole failed to work the following day.There was no patient impact after the procedure.Refer to manufacturer report #1045254-2018-00438.

• Brand Name: NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 7889686
• Report Number: 1045254-2018-00439
• Device Sequence Number: 1837139
• Product Code: ETN
• UDI-Device Identifier: 00643169782600
• UDI-Public: 00643169782600
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K112686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/17/2022
• Device Model Number: 8229708
• Device Catalogue Number: 8229708
• Device Lot Number: 0215681585
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR