SenTiva
LivaNova
MR Conditional — conditions not yet documented here. We have a Conditional label for this device but the specific scan conditions (field strength, SAR / B1+rms, monitoring requirements) aren't in our records yet. Treat as Not determined and let your MRI team confirm before any scan.
Here's what to do next — you're going to be okay:
- Bring your device card (the wallet card from your surgery) to your appointment. Your MRI team can identify any device from it.
- Call the manufacturer's patient line — the number is on your card. They answer device questions every day.
- Tell your imaging center about your device when you book. They screen every patient before every scan — no one will scan you unless it's safe.
Don't schedule an MRI based on this page alone — your MRI team verifies every device.
What this means for you
MR Conditional — but the conditions are not yet on file. The label exists. The scan rules (field, SAR, monitoring) do not. Treat as Not determined and let your MRI team confirm before any scan.
Here's what to do next — you're going to be okay:
- Bring your device card (the wallet card from your surgery) to your appointment. Your MRI team can identify any device from it.
- Call the manufacturer's patient line — the number is on your card. They answer device questions every day.
- Tell your imaging center about your device when you book. They screen every patient before every scan — no one will scan you unless it's safe.
For information only — your MRI team makes the final decision before any scan. They check every patient, every time.
FDA Recall Alert
Class I — Most SeriousVagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizure frequency or depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device.
💡 What this means for you
This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.
12/11/2024 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousTheir is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.
💡 What this means for you
This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.
1/2/2025 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousTheir is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.
💡 What this means for you
This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.
1/2/2025 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousVagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizure frequency or depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device.
💡 What this means for you
This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.
12/11/2024 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousDuring internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated.
💡 What this means for you
This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.
11/11/2020 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousSentiva generators may reset and become disabled within 60 days of enabling. Physicians can re-enable but devices will continue to be susceptible to resets. If a device experiences this issue, this may lead to additional surgery (premature replacement of generator), or patients may return to baseline seizure frequency or depressive symptoms due to cessation of intended stimulation.
💡 What this means for you
This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.
8/21/2019 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousTheir is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.
💡 What this means for you
This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.
1/2/2025 · View on FDA.gov
⚕️ This information is for reference only. A recall does not necessarily mean your device needs removal. Consult your healthcare provider for medical advice.
Regulatory Info
No 510(k) clearance data available for this device.
Data sourced from openFDA. This is for reference only — consult your healthcare provider for medical advice.
Category
Neuro
Body Region
Vagus Nerve Stimulators
MRI Conditions
MRI conditional up to 3.0T
Clinical Warnings
MANDATORY PRE-SCAN: (1) Program to 0.0 mA OFF for all therapy modes (Normal, Magnet, AutoStim). (2) System diagnostics before and after scan. (3) Patient magnet is MR UNSAFE — must NOT enter scanner room. Scanner: 1.5T or 3.0T horizontal closed-bore only. No open MRI. Exclusion zone C7-T8 with certain coils. SAR limits: Head T/R coil ≤3.2 W/kg, Body coil ≤2.0 W/kg (compatible models only).
Post-MRI Notes
System diagnostics REQUIRED after MRI. Verify lead impedance and generator function. Reprogram therapy settings from 0.0 mA back to prescribed output.
Indexed from FDA records. Conditions on this page have not been verified against the manufacturer's instructions for use.