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

Model Number	8253001
Medical Device Problem Codes	False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during testing, the nim3.0 was not working correctly.There was no known patient impact.
Additional Manufacturer Narrative
H3: product analysis found could not verify not working properly.Pi failure/not this console.Unit presented with software:(gui:v2015.1 0.9.918/dsp:v2015.8.28.1058) and no fault found.H6: codes applicable are fdm b01, fdr c19, fdc d14 and img g02030.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), udi#: (b)(4).H3: product analysis found verified not working properly.Unit presented with a channel 2 electrode failure due to a defective pcba.Unit also presented with a cracked lid, a cracked enclosure, worn wave washers, a broken clip, missing spare fuses, and torn o-rings.H6: codes applicable are fdm b01, fdr c0201, c0601, c07, c0706, c070603, fdc d16 and img g02005, g0201202, g0405204, g04070, g04111, g04138.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
Additional information received that output signal was not right.There was no patient impact.
Additional Manufacturer Narrative
H6: previously applied codes ime e2401, fdd a0908, imf f24 are no longer applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant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.
Additional Manufacturer Narrative
H6: code applicable is fdc d20.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), udi#: (b)(4) h6: previously applied code fdc d16 is no longer applicable.Applicable code is fdc d02.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® 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: 22891923
• Report Number: 1045254-2025-02035
• Device Sequence Number: 14903628
• Product Code: ETN
• UDI-Device Identifier: 00643169782549
• UDI-Public: (01)00643169782549(11)170419
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 11/06/2025

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: 10/08/2025; 11/06/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 11/03/2025; 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2017
• 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....".; "SEE H11....".
• Patient Sex: Unknown