Senza II™ Spinal Cord Stimulation System (Model IPG2000)

Nevro

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.

Regulatory Info

No 510(k) clearance data available for this device.

✅No Recalls Found

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

Category

Neuro

Body Region

Spinal Cord Stimulators

MRI Scan Parameters

Max Field Strength3.0T

MRI Conditions

MR Conditional at 1.5T and 3.0T closed-bore environments. • Nevro requires an automated lead impedance check via the patient remote immediately prior to the scan. If the leads have minor structural fractures or high resistance, the remote will block "MRI Mode" entry and the scan must be aborted. • Certain legacy Senza II configurations carry explicit warnings against using specific local transmit/receive volume coils — verify configuration with the device clinic before scheduling.

Clinical Warnings

MRI conditional with specific protocols. Some models full-body MRI, others head-only or limited. Verify model-specific conditions.

Post-MRI Notes

Interrogate device after MRI to verify settings.

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