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

Model Number	8253410
Medical Device Problem Codes	Mechanical Problem (1384); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 use, the nim 3.0 patient interface was intermittently not working when the probe was attached to the stim 1 port.There was no patient impact.
Event or Problem Description
It was reported that during use, the nim 3.0 patient interface was intermittently not working when the probe was attached to the stim 1 port.The port does not seem to have any physical damage however, some of the probes feel loose when connected.There was no pat ient impact.
Additional Manufacturer Narrative
Correction in b5: the event description has been updated based on the available information, which was not included in the previous report.Additionally, the updated information indicates that there is no evidence to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury, or that the device has malfunctioned.Therefore, this event does not meet the reporting requirements outlined in 21 cfr 803.As a result, the previous report was submitted in error, as the complete available information was not evaluated during the initial review of 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.

• Brand Name: NIM-NEURO® PATIENT INTERFACE
• 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: 22166563
• Report Number: 1045254-2025-01482
• Device Sequence Number: 15755417
• Product Code: GWF
• UDI-Device Identifier: 00643169283299
• UDI-Public: (01)00643169283299(11)160613(21)X06705753
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K083124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

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: 8253410
• Device Catalogue Number: 8253410
• Device Lot Number: 211436146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 08/15/2025
• Date Device Manufactured: 06/13/2016
• 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
• Patient Sex: Unknown