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

Model Number	8229706
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that the nim trivantage emg tube was not picking up vocal cord movement (not sensing) at the blue section (contact electrode) intraoperatively.There was no patient injury.
Additional Manufacturer Narrative
The product analysis indicates one opened sample of part number 8229706 from lot number 0213840472 was received.There was a residue consistent with biological contaminants on the device.There was tape wrapped around the tube from the proximal end of the tube, to just before the electrode contacts.A microscope and multimeter were used to evaluate the device.Visually, there was no damage or anomalies in the construction of the device that would have resulted in the reported event.The resistance of the electrodes from end to end shall be less than 200 ohms and the actual measurement of each circuit (respectively) are as follows; red 11 ohms, red [w/white band] 13 ohms, blue 13 ohms, and blue [w/white band] 10 ohms.There were no open circuits or out of specification condition of the main tube electrodes.There were no shorts between circuits and no intermittent behavior while manipulating the tube and wires.When viewed under magnification, there were no cracks in the electrode contacts.There was no fault found and no evidence of improper manufacturing.The reported issue could not be confirmed.If information is provided in the future, a supplemental report will be issued.

• 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: 7157255
• Report Number: 1045254-2018-00003
• Device Sequence Number: 100429
• Product Code: ETN
• UDI-Device Identifier: 00643169782587
• UDI-Public: 00643169782587
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K112686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2018

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: 08/14/2021
• Device Model Number: 8229706
• Device Catalogue Number: 8229706
• Device Lot Number: 0213840472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2017
• Supplement Date Received by Manufacturer: 01/16/2018
• Initial Report FDA Received Date: 01/02/2018
• Supplement Report FDA Received Date: 02/09/2018
• Patient Sequence Number: 1