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); Inappropriate Audible Prompt/Feedback (2280); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the devices were initially on wireless mode when the unit indicated that the battery of the patient interface was running out.This led to the discovery that the cable was not functioning and the wire connection to the patient interface was disconnecting.Initially, the user thought it was the wire cord, so they replaced the wire.However, a few minutes later, it still disconnected.The user then changed the patient interface, but it still had the same result.So, changed the console and it started working.The user tested the unit before the case started, and it was connecting and reading well.However, in the middle of the case, the cord connection disconnected again.The patient interface tried to connect in wireless mode, but it did not work.Static noise and a huge spike were observed when an esu was activated.The patient interface cables were broken.The procedure was completed with another nim console and patient interface.There was no patient impact.
Additional Manufacturer Narrative
H3: analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: 1.Product id: nim4cam1, serial/lot #: (b)(6); h6: fdm b17, fdr c20, fdc d16 and img-g04003 codes are applicable.2.Product id: nim4cpb1, serial/lot #: (b)(6), udi#: (b)(4); 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: fdm b21, fdr c21, fdc d16 and img-g02005 codes are applicable.3.Product id: nim4cpb2, serial/lot #: (b)(6), udi#: (b)(4); h6: fdm b17, fdr c20, fdc d16 and img-g02004 codes are 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
H3: product analysis found that verified not working.Broken connector on the eic board.H6: previously applied fdm b21, fdr c21, fdc d16 and img g02030 codes are no longer applicable.Fdm b01, fdr c0706, fdc d02 and img g02005 code are applicable.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: nim4cam1, serial/lot #: (b)(6).H6: previously applied fdc d16 code has been updated to d20.Product id: nim4cpb1, serial/lot #: (b)(6)/219870597, udi#: (b)(4).H3: product analysis found that could not verifiy the customer complaint with patient interface.H6: previously applied fdm b21, fdr c21 and fdc-d16 codes has been updated to fdm b01, fdr c19 and fdc-d20.Product id: nim4cpb2, serial/lot #: (b)(6), udi#: (b)(4).H6: previously applied fdc d16 code has been updated to d20.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: 21456446
• Report Number: 1045254-2025-00587
• Device Sequence Number: 20753278
• Product Code: GWF
• UDI-Device Identifier: 00763000002978
• UDI-Public: 00763000002978
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K200759
• 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
• Report Date (Section B): 04/08/2025

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
• Device Lot Number: 219924264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 04/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2020
• 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