Vercise Genus™ P-Series (Non-Rechargeable DBS - Models P8 / P16 / P32)
Boston Scientific
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 SeriousThe performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufactured prior to December 2009, may be compromised over time, causing increased current drain that can lead to premature battery depletion.
💡 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.
8/28/2013 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousThe performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufactured prior to December 2009, may be compromised over time, causing increased current drain that can lead to premature battery depletion.
💡 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.
8/28/2013 · 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.
2 past recalls — all corrective actions completed
Data sourced from openFDA. This is for reference only — consult your healthcare provider for medical advice.
Category
Neuro
Body Region
Deep Brain Stimulators
MRI Scan Parameters
MRI Conditions
MR Conditional for standard clinical 1.5T closed-bore MRI scans. • MRI Mode protocol: clinician must place the device into a dedicated "MRI Mode" before the patient enters the magnet room. • Lead requirement: MR Conditional only when paired with native Boston Scientific leads (e.g., Cartesia™ X directional leads). If a Vercise Adapter is used to splice the Genus battery onto a legacy Medtronic or Abbott lead in the brain, MR Conditional parameters tighten significantly or the system becomes MR Unsafe depending on the legacy hardware configuration.
Post-MRI Notes
Device should be interrogated after MRI to verify settings.
Indexed from FDA records. Conditions on this page have not been verified against the manufacturer's instructions for use.