MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM VITAL¿ PATIENT INTERFACE 4 CHANNEL; STIMULATOR, NERVE

Model Number	NIM4CPB1
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during servicing the patient interface had wireless connection issues.There was no patient involvement.
Additional Manufacturer Narrative
H3: device analysis found that complaint was confirmed.Unit presented with software v1.7.5, main board failure and bad antenna cable.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: nim4cm01, serial/lot #: (b)(6), udi#: (b)(4).G3: mfg date: 14.04.2022.H6: the codes fdm b17, fdr c20, fdc d16 and img g02030 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
H6: initially submitted code fdc d16 is no longer applicable for nim patient interface, fdc d1102 is applicable for nim patient interface.Continuation of d10: section d information references the main component of the system.H3: device analysis found that complaint was confirmed.Unit presented with software v1.7.5, main board failure and bad antenna cable.H6: initially submitted codes fdm b17, fdr c20 and fdc d16 are no longer applicable, fdc d20 is applicable for nim console.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable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 VITAL¿ PATIENT INTERFACE 4 CHANNEL
• 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: 22892240
• Report Number: 1045254-2025-02044
• Device Sequence Number: 5986694
• Product Code: ETN
• UDI-Device Identifier: 00763000002985
• UDI-Public: (01)00763000002985(11)191121
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/28/2025

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: NIM4CPB1
• Device Catalogue Number: NIM4CPB1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2019
• 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