MAUDE Adverse Event Report: MEDTRONIC XOMED INC. PATIENT INTERFACE NIM4CPB1 NIM 4.0; STIMULATOR, ELECTRICAL, EVOKED RESPONSE

Model Number	NIM4CPB1
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: evaluation of the returned device was not completed at the time of this report.A follow up report will be sent when analysis is complete.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 device would intermittently would not record responses during surgery.User performed electrode check - all channels passing.User checked fuses and found no issues.User reseated electrodes on patient interface- issue still present afterward.Site adjusted threshold and stim output - issue still present.Site swapped out stimulator probe - issue still present.Site swapped out patient interface - issue resolved.User checked console and patient interface with patient simulator after the case and could not replicate the issue.There was no patient impact.
Event or Problem Description
Additional information received that there were zero event tones when the surgeon stemmed what she believed to be nerve.It had no response at all, even when she stemmed what she believed to not be nerve there were no event tones coming from the nim.
Additional Manufacturer Narrative
H3: analysis could not confirm 'not working/intermittent.' misaligned radio firmware, and a worn fuse decal.H6: codes are updated.Previously applied fdm b21, fdr c21, fdc d16 and img g02005 codes no longer applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant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.

• Brand Name: PATIENT INTERFACE NIM4CPB1 NIM 4.0
• 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: 24949931
• Report Number: 1045254-2026-00564
• Device Sequence Number: 5406881
• Product Code: GWF
• UDI-Device Identifier: 00763000528584
• UDI-Public: (01)00763000528584(11)230829
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K200759
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026

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: NIM4CPB1
• Device Catalogue Number: NIM4CPB1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2023
• 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 Age: 17 YR
• Patient Sex: Female
• Patient Weight: 51 KG