MAUDE Adverse Event Report: Medtronic Xomed Inc. NIM 4.0 CONSOLE; STIMULATOR, ELECTRICAL, EVOKED RESPONSE

Model Number	NIM4CM01
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/30/2026
Type of Reportable Event	Malfunction

• 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 ; +1(763)526-5677
• MDR Report Key: 50407213
• Report Number: 1045254-2026-01181
• Device Sequence Number: 21470348
• Product Code: GWF
• UDI-Device Identifier: 00763000528577
• UDI-Public: (01)00763000528577(11)250414
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

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
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 08/24/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2025
• 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