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

Model Number	8229706
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Nerve integrity monitor emg endotracheal tube failed to recover any impulses from left side.Right side electrodes worked.System checked with assistance from rep, which confirmed problem with et tube.All other equipment had been changed and the problem continued.The surgeon was unable to detect nerve response while completing a thyroidectomy.
Event or Problem Description
Nerve integrity monitor emg endotracheal tube failed to recover any impulses from left side.Right side electrodes worked.System checked with assistance from rep, which confirmed problem with et tube.All other equipment had been changed and the problem continued.The surgeon was unable to detect nerve response while completing a thyroidectomy.

• Brand Name: NIM TRIVANTAGE®
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED, INC.; 6743 southpoint dr. north; jax FL 32216
• MDR Report Key: 7863866
• Report Number: 7863866
• Device Sequence Number: 1950793
• Product Code: ETN
• UDI-Device Identifier: 00643169782587
• UDI-Public: (01)00643169782587
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2018
• Report Date (Section F): 08/28/2018

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 Model Number: 8229706
• Device Catalogue Number: 8229706
• Device Lot Number: 0214767972
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 09/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 08/28/2018