Magnetic Resonance Imaging (MRI)
The Enterra™ Therapy System is MR Unsafe — Patients with an implanted Enterra or Enterra II Therapy System should not be exposed to the electromagnetic fields produced by Magnetic Resonance Imaging (MRI). The interaction of the MRI with the neurostimulation system may lead to serious injury or death. Use of MRI may also result in system failure, dislodgement, heating, or induced voltages in the neurostimulator and/or lead. An induced voltage through the neurostimulator or lead may cause uncomfortable, “jolting,” or “shocking” levels of stimulation.
MKT-D-0003, Rev G
IMPORTANT SAFETY INFORMATION
Enterra Therapy for treatment of chronic, resistant to medication nausea and vomiting associated with gastroparesis caused by diabetes or an unknown origin in patients aged 18 to 70 years: patients should always discuss potential risks and benefits of the device with their physician.
Authorized by Federal law for use in the treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 to 70 years. The effectiveness of this device for this use has not been demonstrated. What does this mean?