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

Model Number	8229707
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Ett [endotracheal tube] inserted and balloon would not inflate.Ett extracted and discarded.A second et tube inserted and balloon inflated, but leaks were heard/noted throughout case.Surgeon able to complete case with this second ett.After extubation, resident examined ett and did not visualize any defects, but noted the balloon was slow to inflate.He then placed ett in saline and inflated balloon.Bubbles were noted, indicating a hole in the balloon.

• 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: 25299648
• Report Number: 25299648
• Device Sequence Number: 15794840
• Product Code: ETN
• UDI-Device Identifier: 00763000033958
• UDI-Public: (01)00763000033958(17)300316(10)0233453432
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/18/2026
• Report Date (Section F): 05/18/2026

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: 8229707
• Device Lot Number: 0233453432
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/27/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 99 KG
• Date Report Sent to FDA: 05/18/2026