Model note · IONM
Medtronic NIM Vital Nerve Integrity Monitor
The NIM Vital (console NIM4CM01, named NIM 4.0 in FDA recall records) is an intraoperative EMG nerve monitor used in thyroid, head and neck, ENT, spinal and peripheral surgery to locate and continuously check nerves at risk. It records EMG from muscles supplied by the nerve and alerts the surgeon visually and audibly when the nerve is stimulated or its response trends down. It adds a wireless patient interface, software electrosurgery muting and continuous Nervassure monitoring over its NIM 3.0 predicate.
The model
Maker, model and type.
- Maker
- Medtronic Xomed, Inc.
- Model
- NIM Vital Nerve Integrity Monitor (console NIM4CM01, listed by FDA as NIM 4.0)
- Device type
- IONM
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Main components | Touchscreen console, patient interface (wired or wireless) and cart; uses NIM 3.0 disposables through adaptors | Source |
| Console power | 100 to 240 V plus or minus 10%, 50/60 Hz, with battery backup | Source |
| Patient interface power | DC from the console when wired; internal battery when wireless | Source |
| Maximum stimulation current | 50 mA (NIM 3.0: 30 mA) | Source |
| Electrosurgery muting | Wired mute detector or software detection without a mute detector | Source |
| Monitoring modes | Intermittent stimulation with NerveTrend reporting, Automatic Periodic Stimulation (APS) and continuous Nervassure monitoring | Source |
| Compatible muting probe | Metal Muting Probe, Ref 8220325, only | Source |
| FDA clearance | 510(k) K200759, decision 28 October 2020, 21 CFR 882.1870, product code GWF, Class II; predicate NIM 3.0 (K083124) | Source |
| Maintenance interval | Functional and safety checks at least once a year | Source |
Recalls
Known FDA recalls.
- Z-1623-20252025-03-10
Certain software versions may produce increased stimulus artefact; fixed in software 1.7.5.
FDA record - Z-2409-20242024-06-24
Potential for false negative response; fixed in software 1.5.4.
FDA record
Safety
Safety warnings from the record.
- Paralysing anaesthetic agents that suppress EMG are contraindicated; muscle activity must return before monitoring is relied on. Source
- Stray electrosurgical current can cause burns at other sites; avoid activating the ESU while the stimulator touches tissue or near electrodes. Source
- Remove continuous monitoring electrodes before external defibrillation to prevent thermal injury. Source
- Above 3 mA with Slim Prass or Prass Bipolar probes, current density may damage tissue. Source
- A false negative can leave a nerve unprotected, so the surgeon must still rely on anatomy and other methods. Source
Sources
Where this note comes from.
- Medtronic, NIM Vital product page (Middle East)
- Medtronic, NIM Vital indications, safety and warnings
- FDA 510(k) summary K200759, NIM Vital
- openFDA recall search, NIM 4.0
- openFDA MAUDE problem counts, NIM 4.0
Not covered: The NIM Vital user manual and service manual were not found publicly, so system error messages, channel count and the impedance limits are not listed. The 510(k) table gives stimulation figures in a garbled layout, so only the maximum current is quoted.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
IONM