MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM 4.0 CONSOLE; STIMULATOR, ELECTRICAL, EVOKED RESPONSE

Model Number	NIM4CM01
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Misassembled During Manufacturing /Shipping (2912); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: n im4cbp1, serial number: unknown.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 console needs a complete check- up.The battery does not work, or is missing, one of the usb ports is damaged.Bluetooth connection is not stable despite it being on latest software version.There was no known patient impact.
Additional Manufacturer Narrative
B5: updated.H3: analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.H6: previously submitted codes ime e2401, fdm b17, fdr c20 and imf f24 are no longer applicable.Initial aware date was 2025-05-01, as the medtronic representative was present in the event.Medtronic submits this report to comply with fda regulations 21 cfr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 event occurred during testing.There was no patient involved.
Additional Manufacturer Narrative
H3: analysis found the battery was missing, usb port on side of the screen was damaged.Ssd card was old version and not fully compatible with new software.Pi cable port doesn't respond.H6: previously submitted codes fdm b21, fdr c21 and fdc d16 are no longer applicable.Fdc code d20 is applicable for product number: nim4cbp1 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 ; 7635265677
• MDR Report Key: 22392177
• Report Number: 1045254-2025-01655
• Device Sequence Number: 9104657
• Product Code: GWF
• UDI-Device Identifier: 00763000002978
• UDI-Public: (01)00763000002978(11)200414
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K200759
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2025

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: NIM4CM01
• Device Catalogue Number: NIM4CM01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: 08/13/2025; 09/12/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 09/08/2025; 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2020
• 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