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

Model Number	8229706
Medical Device Problem Codes	Unable to Obtain Readings (1516); Use of Device Problem (1670); Noise, Audible (3273)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2018
Type of Reportable Event	Malfunction
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 via a manufacturer representative that when they were using a nerve monitoring device, there was a problem with the endotracheal tube and they experienced issues with the leads on the tube.They could not monitor the nerve response during a thyroidectomy procedure.The system was not receiving responses from the left or right side and the system was sounding.Troubleshooting was done and found right side was not working as it failed to receive any impulses from left side.The hcp discontinued to use the device and system for monitoring.The procedure was completed without use of the monitoring system and troubleshooting was not continued.There was a slight delay in the procedure due to troubleshooting.There was no patient impact and there was no re-intubation needed.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.(b)(4).
Event or Problem Description
(b)(4).
Additional Manufacturer Narrative
Analysis found that electrically, the resistance of the tube electrodes from end to end shall be less than 200 ohms and the actual measurements were; red 10 ohms, red [w/white band] as low as 32 ohms but up to open circuit, blue as low as 35 ohms but up to open circuit, and blue [w/white band] open circuit.The resistance readings are out of specification.There were no shorts between circuits.The product instructions ¿ the silver trace is printed onto the tube and verified they do not contain smudges, cracks, scratches or voids that exceed 0.8mm2; an adhesive coating is applied over a portion of the silver ink trace; the clamp shell and wires are attached; loctite is applied to, and next to, the clamp shell.When viewed under magnification, there were a crack and voids in the conductive ink, from the clamp shell to the exposed electrical contacts.The cracks and voids directly correlate to the increased resistance and open circuits.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: 7905142
• Report Number: 1045254-2018-00458
• Device Sequence Number: 11209261
• Product Code: ETN
• UDI-Device Identifier: 00643169782587
• UDI-Public: 00643169782587
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K112686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2019

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: 01/21/2022
• Device Model Number: 8229706
• Device Catalogue Number: 8229706
• Device Lot Number: 0214767972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/21/2018; 02/07/2019
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 10/17/2018; 02/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR