NIM 4.0 CONSOLE
Received Jul 31, 2026 · Event occurred Jul 8, 2026
Report 1045254-2026-01066 · MDR key 50096448
Device
Generic name
Stimulator, Electrical, Evoked Response
Manufacturer
Medtronic Xomed Inc.Model number
NIM4CM01Catalog number
NIM4CM01
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that PI Fault message displaying on the console, during a wireless connection. Rep switched to a wired connection-- issue persisted, have been able to get error messages to clear but they eventually reappear. site swapped to another PI box. There was no patient involvement.
Additional Manufacturer Narrative
Continuation of D10: Section D information references the main component of the system. Other relevant device(s) are: Product Id: NIM4CPB1, Serial/Lot #: (b)(6) , UDI#: (B)(4). 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.