MAUDE Adverse Event Report: Medtronic Xomed Inc. NIM 4.0 CONSOLE; STIMULATOR, ELECTRICAL, EVOKED RESPONSE

Model Number	NIM4CM01RF
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	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that intra-op, the nim console had not stimulation properly, switched from brief tone to continuous, at first there was no stimulation response but when probe was removed and put back on the nerve it gave an overwhelming response.No patient impact or injury.
Additional Manufacturer Narrative
H6: the codes fdm b17, fdr c20, fdc d16 and img g02030 are applicable for nim console.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: nim4cpb1rf, serial/lot #: (b)(6), ubd: , udi#: (b)(4).H6: the codes fdm b17, fdr c20, fdc d16 and img g02005 are applicable for nim patient interface.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 4.0 CONSOLE
• Common Device Name: STIMULATOR, ELECTRICAL, EVOKED RESPONSE
• 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 ; +1(763)526-5677
• MDR Report Key: 50877735
• Report Number: 1045254-2026-01300
• Device Sequence Number: 9379996
• Product Code: GWF
• UDI-Device Identifier: 00763000002992
• UDI-Public: (01)00763000002992(11)230926
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K200759
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: NIM4CM01RF
• Device Catalogue Number: NIM4CM01RF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 09/26/2023
• 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