Model note · VNS
MicroTransponder Vivistim Paired VNS System
Vivistim is an implanted vagus nerve stimulator for chronic ischaemic stroke patients with moderate to severe arm impairment. Instead of running on a fixed duty cycle like epilepsy VNS, it delivers short bursts that a therapist triggers in time with rehabilitation movements, using a laptop application and a USB radio transmitter. Patients can also start home sessions by swiping a magnet over the generator.
The model
Maker, model and type.
- Maker
- MicroTransponder, Inc.
- Model
- Vivistim Paired VNS System (IPG 1001, Lead 3000, Wireless Transmitter 2000/2100, SAPS 4001)
- Device type
- VNS
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Output current | 0.0 to 3.5 mA in 0.1 mA steps; accuracy plus or minus 0.1 mA up to 1.0 mA, plus or minus 10% above | Source |
| Frequency | 1, 2, 5, 10, 15, 20, 25 or 30 Hz, within 1% | Source |
| Pulse width | 10 to 1000 microseconds, within 2 microseconds or 1% | Source |
| Train duration | 0.5 to 60 s | Source |
| Magnet activation | Magnet field present for 10 ms plus or minus 1 ms starts stimulation 65 ms plus or minus 25 ms later; holding the magnet stops stimulation | Source |
| Telemetry | MICS band, about 403 MHz, up to 1 m; transmitter powered from laptop USB with a 2 m cable | Source |
| Lead | Silicone insulated, bifurcated bipolar lead with two helical nerve cuffs and an anchor tether; 2 mm and 3 mm cuffs | Source |
| Battery voltage measurement accuracy | Plus or minus 50 mV | Source |
| FDA approval | PMA P210007, 27 August 2021, breakthrough device designation | Source |
| Wireless transmitter update | Model 2000 replaced by Model 2100 for an obsolete part (supplement S001, 2022) | Source |
Recalls
Recalls.
This note lists no recalls. Check the FDA recall database for the latest record.
Safety
Safety warnings from the record.
- Contraindicated after bilateral or left cervical vagotomy. Source
- Stimulation can cause hoarseness, coughing, swallowing difficulty or discomfort, and implantation can damage the vagus or nearby nerves. Source
- The system is MRI Conditional, so scans need the labelled conditions to be checked first. Source
Sources
Where this note comes from.
- FDA PMA P210007 Summary of Safety and Effectiveness Data, Vivistim Paired VNS System
- openFDA MAUDE problem counts, brand VIVISTIM
- openFDA PMA supplement listing, Vivistim
Not covered: Battery capacity, expected longevity, IPG size and full MRI conditions are in the Vivistim labelling, which was not read. SAPS messages and error codes are not public. No recall matched Vivistim. The manufacturerUrl points to the FDA summary.
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.