Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (DBS, DBS Neurostimulator Implantable, DBS Neuros

Medtronic, Inc.

Not determinedIndexed from FDA records

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:

  1. Bring your device card (the wallet card from your surgery) to your appointment. Your MRI team can identify any device from it.
  2. Call the manufacturer's patient line — the number is on your card. They answer device questions every day.
  3. 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:

  1. Bring your device card (the wallet card from your surgery) to your appointment. Your MRI team can identify any device from it.
  2. Call the manufacturer's patient line — the number is on your card. They answer device questions every day.
  3. 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.
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For information only — your MRI team makes the final decision before any scan. They check every patient, every time.

✅This recall has been resolved
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FDA Recall Alert

Class II — Moderate

Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling feature that, when enabled, allows stimulation output to be toggled on and off based on the programmed settings. The use of this feature is determined by the physician and set using the clinician programmer. Current labeling indicates the use of cycling improves device longevity and recharge interval

💡 What this means for you

This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.

2/26/2014 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class II — Moderate

A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device.

💡 What this means for you

This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.

11/18/2020 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class II — Moderate

Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulators under the following specific conditions: Switching between groups with Multiple programs or creating program groups. Therapy can be restored with the Physician Recharge mode (RPM) of the Implantable Neurostimulator Recharger (INSR).

💡 What this means for you

This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.

9/29/2013 · View on FDA.gov

⚠️

FDA Recall Alert

Class I — Most Serious

Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling feature that, when enabled, allows stimulation output to be toggled on and off based on the programmed settings. The use of this feature is determined by the physician and set using the clinician programmer. Current labeling indicates the use of cycling improves device longevity and recharge interval

💡 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.

11/6/2014 · 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.

⚠️1 Active Recall

Data sourced from openFDA. This is for reference only — consult your healthcare provider for medical advice.

Category

Neuro

Body Region

Deep Brain Stimulators

Model

P960009

MRI Conditions

MRI Conditional — check manufacturer labeling for specific conditions (field strength, SAR limits, lead configuration).

🔔 Get Recall Alerts for Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (DBS, DBS Neurostimulator Implantable, DBS Neuros
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Indexed from FDA records. Conditions on this page have not been verified against the manufacturer's instructions for use.