MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM® 3.0 MAINFRAME INTERNATIONAL; STIMULATOR, NERVE

Model Number	8253002
Medical Device Problem Code	Inappropriate Audible Prompt/Feedback (2280)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis found the customer complaint can't be confirmed.No deviations found.The software is up to date.Ver: 2.0.0.0; gui v2014.11.11.921; dsp v2014.2.12.833 is present.H6: codes applicable are fdm b01, fdr c19, fdc d14, d20 and additional codes img g02030.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 8253200, serial/lot #: (b)(6), udi#: (b)(4), h3: product analysis found the customer complaint can be confirmed.The second channel of the patient interface is not stable.Pcba is worn.The clamps were loose.H6: codes applicable are fdm b01, fdr c0601,c070603, fdc d02 and additional codes img g02005, g0405204.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during thyroidectomy procedure, the device constantly sends false signals, making it impossible to read signals from the laryngeal nerve.The device gives an permanent voice signal and graphic on the screen similar to when there are artifacts recognized.They tried stimulating, but from the response of the device, it was impossible to read the signals.Repositioning of the tube was performed and the procedure was completed without nerve monitoring.There was no patient impact.

• Brand Name: NIM® 3.0 MAINFRAME INTERNATIONAL
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: justin ellis ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635265677
• MDR Report Key: 21991273
• Report Number: 1045254-2025-01294
• Device Sequence Number: 18285711
• Product Code: ETN
• UDI-Device Identifier: 00613994529053
• UDI-Public: 00613994529053
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K083124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/09/2025

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: 8253002
• Device Catalogue Number: 8253002
• Device Lot Number: 208396356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Patient Sex: Unknown