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

Model Number	8229708
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.A product analysis has not been performed.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
It was reported that the trivantage emg tube was not responding normally.The physician opted to continue the procedure with the reported product.During the procedure, the physician attempted to use the nim as much as he/she could.Disconnection and/or fracture was suspected.There was no patient injury.
Additional Manufacturer Narrative
Device returned on jan/06/2017.Date mfr.Rec: jan/26/2017.One un-sealed sample of part number 8229708, from lot number 0210438814 was received.There was a red mark (appears to be from a marker) around the circumference of the main tube at the electrode contacts.There was a sticky substance around the grey clamp shell consistent with medical tape adhesive.Visually there was no damage or anomalies in the construction of the device.The resistance of the electrodes from end to end shall be less than 200 ohms and the actual measurement of each circuit are as follows; red 18 ohms, red [w/white band] 19 ohms, blue 17 ohms, and blue [w/white band] 19 ohms.There were no open circuits and no 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.There were no cracks in the electrode contacts.Per the xvi a continuity test is performed prior to final packaging.The ifu provides contraindications and warnings that identify reasons why a user may experience reduced or eliminated emg responses to direct or passive neural stimulation such as; paralyzing agents / lubricants / sprays, neuromuscular fatigue from prolonged or repeated exposure to electrical stimuli, deep anesthesia, which may suppress neuroelectrical activity, insufficient contact between the electrodes and vocal cords due to misplacement or using a tube size that is too small, and displacement during the procedure when rotating, flexing, or extending the patient¿s head and neck.There was no fault found and no evidence of improper manufacturing, therefore manufacturing has been ruled out as a likely cause.(b)(4).
Additional Manufacturer Narrative
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: 6249326
• Report Number: 1045254-2017-00023
• Device Sequence Number: 19048763
• Product Code: ETN
• UDI-Device Identifier: 00643169060807
• UDI-Public: 00643169060807
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/20/2016

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: 11/16/2019
• Device Model Number: 8229708
• Device Catalogue Number: 8229708
• Device Lot Number: 0210438814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2017
• Initial Date Received by Manufacturer: 12/20/2016
• Supplement Date Received by Manufacturer: Not provided; 01/26/2017
• Initial Report FDA Received Date: 01/13/2017
• Supplement Report FDA Received Date: 02/20/2017; 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1