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

Model Number	8253001
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review through capa 624392.H3: product analysis found confirmed the customer complaint regarding no nerve reaction.The unit came in with pcba patient interface adapter failure, stim 1 not working.H6: codes applicable are fdm b01, fdr c0208, fdc d02 and additional code img g02005.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) ubd: , udi#:(b)(4).Manufactured date: 2021-03-30.H3: product analysis found, examined unit and could not duplicate the customer complaint regarding no nerve reaction.However, the unit came in with missing o-rings and loose clips.H6: codes applicable are fdm b01, fdr c07, c070603, fdc d20 and additional code img g0405204 and g04111.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 during testing, the system was not giving any response with the simulator.Troubleshooting performed.The console was reading/picking up responses by lightly tapping on the electrodes plugged into the interface box.Then tried to stimulate a corresponding electrode pair and there was no response from the system.Moved the probe to stim 2 and adjust the stim/threshold and got a response.Plugged back into stim 1 and adjusted the stim/threshold values and there was still no response on the system.There was no patient involved.

• Brand Name: NIM® 3.0 MAINFRAME
• 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: 21593494
• Report Number: 1045254-2025-00832
• Device Sequence Number: 20952097
• Product Code: ETN
• UDI-Device Identifier: 00643169782549
• UDI-Public: 00643169782549
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 03/13/2025

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: 8253001
• Device Catalogue Number: 8253001
• Device Lot Number: 217555294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2019
• 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