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                                            Safety Information Article
                      Information on this page is limited by the terms of our Disclaimer.  Please Read!

       ENTERRA THERAPY, Gastric Electrical Stimulation (GES), Neurostimulation System 

NEUROSTIMULATION SYSTEM: 
ENTERRA THERAPY, GASTRIC ELECTRICAL STIMULATION (GES)

The Enterra Therapy, Gastric Electrical Stimulation (GES) System(Medtronic, Inc., Minneapolis, MN), is a neurostimulation system indicated for treatment of patients with chronic, intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology. Enterra Therapy uses mild electrical pulses to stimulate the stomach. This electrical stimulation helps to control the symptoms associated with gastroparesis, including nausea and vomiting. 

Models: Models 3116 and 7425 G

Patients with an implanted device should not be exposed to the electromagnetic fields produced by magnetic resonance imaging (MRI). Use of MRI may potentially result in system failure or dislodgment, 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.

Clinicians should carefully weigh the decision to use MRI in patients with an implanted neurostimulation system, and note the following: 
• Magnetic and radio-frequency (RF) fields produced by MRI may change the neurostimulator settings, activate the device, and injure the patient. 
• Patients treated with MRI should be closely monitored and programmed parameters verified upon cessation of MRI.

[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.] 

REFERENCE
www.medtronic.com/mri



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