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

Model Number	8253002
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate Audible Prompt/Feedback (2280)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2022
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 the customers complaint can't be confirmed; the electrodes were working.The mute cable can't be inserted, connector from audio pcb board is broken.The nim response 3.0 has been received with software version: 2.0.0.0.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 the mainframe wasn't recognizing the electrodes when attached.There appears to have been some piece of equipment in a theatre close by or some hospital plant equipment above the theatre which was causing electrical interference with the nim.This issue only occurred in this theatre.The biomedical engineering department have tested all equipment in that theatre and unfortunately the cause of the electrical interference was not located.This was just before surgery as the team were preparing the patient they were unable to get confirmation from the nim that the electrodes were correctly placed.There was no green tick indicators.There was no patient injury.

• Brand Name: NIM® 3.0 MAINFRAME INTERNATIONAL
• 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: 21536071
• Report Number: 1045254-2025-00739
• Device Sequence Number: 12526323
• Product Code: ETN
• UDI-Device Identifier: 00613994529053
• UDI-Public: 00613994529053
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/06/2025

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: 8253002
• Device Catalogue Number: 8253002
• Device Lot Number: 205767571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2012
• 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