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

Model Number	8229708
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During a thyroidectomy, the nerve integrity monitor's (nim) return electrodes kept moving from a functioning to nonfunctioning status.Laterality of the return electrodes also kept showing this variance.Electrodes were checked and in good placement (subcutaneous tissue of chest).A second machine was brought to the room and used and the same errors replicated on this machine.Surgeon unable to use stim for nerve check.

• Brand Name: NIM TRIVANTAGE
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• MDR Report Key: 11991089
• Report Number: 11991089
• Device Sequence Number: 4305755
• Product Code: ETN
• UDI-Device Identifier: 00643169782600
• UDI-Public: (01)00643169782600(17)230916(10)0218500470
• 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
• Report Date (Section B): 05/26/2021
• Report Date (Section F): 05/26/2021

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: 8229708
• Device Catalogue Number: 8229708
• Device Lot Number: 0218500470
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/14/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/14/2021
• 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: 05/26/2021