MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM-NEURO® PATIENT INTERFACE; STIMULATOR, NERVE

Model Number	8253410
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: it was found in the analysis that the wave washer was worn.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 8253401, product description: mainframe 8253401 nim neuro 3.0; serial/lot #: (b)(6), udi#: (b)(4) h3: serial number: (b)(6): it was found in the analysis that the interface pcb was defective.H6: serial number: (b)(6): fdm b01, fdr c0201, img g02005, and fdc d02 codes are applicable.Product id: 8253200, product description: patient interface 8253200 response 3.0, serial/lot #: (b)(6), udi#: (b)(4); h6: serial number: (b)(6): fdm b17, fdr c20, img g02005, and fdc d16 codes are applicable.Product id: 8253001, product description: mainframe 8253401 nim neuro 3.0, serial/lot #: (b)(6), udi#: (b)(4) h6: serial number: (b)(6): fdm b17, fdr c20, img g02030, and fdc d16 codes are applicable.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during pre-op, the patient interface and mainframe channel was not working.It did not display nerve stimulation in a craniotomy.They brought in a second system; it did not work either.During troubleshooting the case ended and tested the device with the patient simulator and both units seemed to operate correctly.The procedure was completed without nerve monitoring.There was no patient impact.
Additional Manufacturer Narrative
H6: fdc d02 code is no longer applicable.H6: serial number: (b)(6): fdc d1102 code is applicable.H6: serial number: (b)(6): fdc d16 code no longer applicable.H6: serial number: (b)(6): fdc d02 code is applicable.H6: serial number: (b)(6): fdc d16 code no longer applicable.H6: serial number: (b)(6): fdc d02 code is applicable.H6: serial number: (b)(6): fdc d16 code no longer applicable.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: NIM-NEURO® PATIENT INTERFACE
• 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: 23669355
• Report Number: 1045254-2025-02647
• Device Sequence Number: 13190673
• Product Code: ETN
• UDI-Device Identifier: 00643169782464
• UDI-Public: (01)00643169782464(11)240913
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K083124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2026

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: 8253410
• Device Catalogue Number: 8253410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 11/28/2025
• Supplement Report FDA Received Date: 01/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2024
• 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