Model note · VNS
VNS Therapy SenTiva Generator Model 1000
SenTiva Model 1000 is an implantable vagus nerve stimulator used as add-on therapy for drug-resistant epilepsy, implanted in the chest with a lead to the left vagus nerve and programmed wirelessly in neurology clinics. Its AutoStim mode senses rapid heart rate rises that can accompany seizures and delivers an extra dose, and it adds day-night programming, scheduled dose increases and logging of low heart rate and prone position events.
The model
Maker, model and type.
- Maker
- LivaNova USA, Inc.
- Model
- SenTiva Generator Model 1000
- Device type
- VNS
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Output current | 0 to 2.0 mA in 0.125 mA steps, 2.0 to 3.5 mA in 0.25 mA steps; tolerance 0.1 mA or 10%, whichever is greater | Source |
| Signal frequency | 1, 2, 5, 10, 15, 20, 25, 30 Hz | Source |
| Pulse width | 130, 250, 500, 750, 1000 microseconds | Source |
| Signal ON time | 7, 14, 21, 30, 60 s (Normal and Magnet); 30 or 60 s (AutoStim) | Source |
| Signal OFF time | 0.2 min up to 180 min in set steps | Source |
| Battery | Lithium carbon monofluoride, 3.3 V open circuit, 1 Ah rated capacity, self-discharge under 1% per year | Source |
| Dimensions and weight | 45 x 32 x 6.9 mm, 16 g | Source |
| Materials | Hermetic titanium case, polyurethane header, stainless steel connector blocks, silicone setscrew plug; 3.2 mm lead receptacle | Source |
| Compatible components | Leads 302, 303, 304; wand 2000; tablet software 3000 v1.0+; tunneler 402; magnets 220 | Source |
| Programmer range | Wireless programmer to wand link up to about 3 m under most conditions | Source |
Recalls
Known FDA recalls.
- Z-1118-20202019-08-13
A subset of generators received one extra sterilisation cycle, outside quality specifications.
FDA record - Z-0561-20202019-08-22
Generators could reset and become disabled within 60 days of enabling and remain susceptible after re-enabling.
FDA record - Z-1072-20252024-12-12
An internal mechanically activated component could stick closed and stop stimulation, risking return to baseline seizures.
FDA record - Z-1067-20252025-01-03
Implanted generators may stop delivering therapy because of an internal component issue.
FDA record
Safety
Safety warnings from the record.
- Do not use short-wave, microwave or therapeutic ultrasound diathermy on patients with a VNS Therapy system. Source
- Perform MRI only as described in the LivaNova MRI instructions; a transmit RF body coil can heat the lead and cause serious injury in some configurations. Source
- Resetting the generator turns it off (0 mA output). Source
- AutoStim should not be used in patients with clinically meaningful arrhythmias, pacemaker dependency, an ICD or beta blockers, and false heart rate detections can cause unintended stimulation. Source
- Bradycardia or asystole has rarely occurred during the intraoperative lead test; be ready to follow ACLS guidance. Source
- Patients should use the magnet to stop stimulation if they suspect a malfunction, since a fault could cause painful or direct current stimulation. Source
Sources
Where this note comes from.
- LivaNova SenTiva M1000 technical information sheet with safety summary
- LivaNova SenTiva HCP product page (UK)
- openFDA PMA records, SenTiva (P970003 supplements)
- openFDA MAUDE problem counts, brand SENTIVA
- openFDA recalls, SenTiva
Not covered: The full physician manual was not opened, so programmer messages, impedance limits, battery replacement indicators and longevity tables are not included; the MAUDE count by brand name is very small and probably undercounts SenTiva reports filed under other brand names.
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.