Percept PC Neurostimulator

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.

⚠️

FDA Recall Alert

Class I — Most Serious

The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.

💡 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.

3/29/2022 · View on FDA.gov

⚠️

FDA Recall Alert

Class II — Moderate

The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.

💡 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.

3/29/2022 · View on FDA.gov

⚠️

FDA Recall Alert

Class I — Most Serious

During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become unresponsive and non-functional. Cardioversion is a procedure performed by a cardiologist to correct an abnormal heartbeat. Medtronic has determined that the cardioversion may damage the circuit electronics in the Percept PC stimulator, thereby, causing the Percept PC stimulator to become non-responsive.

💡 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.

10/18/2021 · View on FDA.gov

⚠️

FDA Recall Alert

Class II — Moderate

The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.

💡 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.

3/29/2022 · View on FDA.gov

⚠️

FDA Recall Alert

Class II — Moderate

During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become unresponsive and non-functional. Cardioversion is a procedure performed by a cardiologist to correct an abnormal heartbeat. Medtronic has determined that the cardioversion may damage the circuit electronics in the Percept PC stimulator, thereby, causing the Percept PC stimulator to become non-responsive.

💡 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.

10/18/2021 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class I — Most Serious

Software issue may cause false low battery alert to be displayed when interrogating an Interstim Implantable Neurostimulator (Model 3023) with an N'Vision Clinician Programmer (Model 8840), or with an Inter Stim iCon Patient Programmer (Model 3037).

💡 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.

6/24/2007 · 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.

⚠️5 Active Recalls

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

Category

Neuro

Body Region

Deep Brain Stimulators

MRI Conditions

MR Conditional at 1.5T under specific conditions (full-body). BrainSense technology records local field potentials. Must use MRI mode before scanning.

Clinical Warnings

Must activate MRI mode before scanning. Only with Medtronic-approved leads. 1.5T only with specific SAR limits.

Post-MRI Notes

Verify stimulation settings after MRI. Check impedances.

Tracked Settings

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Indexed from FDA records. Conditions on this page have not been verified against the manufacturer's instructions for use.