MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM4.0 PATIENT INTERFACE; STIMULATOR, ELECTRICAL, EVOKED RESPONSE

Model Number	NIM4CPB1
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Problem with Software Installation (3013)
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: the device has not been analyzed yet.A supplemental report shall be submitted after the device is analyzed.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id:nim4cm01, serial/lot #: unknown/unknown, udi#: unknown.Applicable code for concomitant product (unk.Prod.Id/ indigo handpiece) - fdm b17, fdr c20, fdc d16 img g02030.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 pre-op, after the software update, bluetooth connections frequently disconnect on ch1 and ch2.There was no patient involvement.
Additional Manufacturer Narrative
H3: analysis of the device found that there were loose pins on channel 1, 2 and stim 1.Continuation of d10: additional information received shows that the other relevant device product id:nim4cm01, serial/lot #: unknown /unknown, udi #: unknown that was reported in regulatory report 1045254-2026-00517 was working fine with other patient interfaces.Therefore, there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803 and does not fulfill the criteria to be a complaint.Correction: the concomitant product was incorrectly mentioned as indigo handpiece but was nim vital console which has been now determined to be not fulfilling the criteria to be a complaint.H6: previous codes a110207, b21, c21 and d16 is no longer valid.G3: pma / 510(k) has been updated.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 the console was working fine with other patient interface.

• Brand Name: NIM4.0 PATIENT INTERFACE
• 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: 24867579
• Report Number: 1045254-2026-00517
• Device Sequence Number: 8951678
• Product Code: GWF
• UDI-Device Identifier: 00763000395902
• UDI-Public: (01)00763000395902(11)221216
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K200759
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/18/2026

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: 03/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Supplement Date Received by Manufacturer: 04/15/2026; 05/15/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 05/04/2026; 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2022
• 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