Safety Information Article
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       Neurostimulation System: RNS System

Neurostimulation System: RNS System

The responsive neurostimulation device or RNS system (Neuropace) is designed for the treatment of medically refractory partial epilepsy and includes implantable and external products. The RNS System is an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures from no more than two foci that are refractory to two or more antiepileptic medications.

Magnetic Resonance Imaging. MRI is contraindicated for patients with an implanted RNS System. Do not perform an MRI on a patient with any implanted RNS Neurostimulator or Lead (or any portion of a Lead). The RNS System is MR Unsafe. Testing has not been performed to define conditions of use to ensure safety of the RNS System in an MR environment.

[MR healthcare professionals are advised to contact the respective manufacturer in order to obtain the latest safety information to ensure patient safety relative to the use of an MR procedure.]


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