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ENTERRA THERAPY FOR GASTROPARESIS: PRODUCT TECHNICAL MANUAL MUST BE REVIEWED PRIOR TO USE FOR DETAILED DISCLOSURE.

This therapy is not for everyone. Please consult your doctor.

		For patients

		For physicians

Indications: The Medtronic Enterra Therapy System for gastric electrical stimulation (GES) is indicated for use in the treatment of chronic, intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology.

Contraindications: The Enterra Therapy System is contraindicated in patients whom the physician determines are not candidates for surgical procedures and/or anesthesia due to physical or mental health conditions.

Do not use shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. Energy from diathermy can be transferred through the implanted system and can cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death.

Diathermy is further prohibited because it can also damage the neurostimulation system components resulting in loss of therapy, requiring additional surgery for system explantation and replacement. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned "on" or "off." Advise your patients to inform all their health care professionals that they should not be exposed to diathermy treatment.

Warnings/Precautions/Adverse Events: This system has not been evaluated for pregnancy, pediatric use, or patients under the age of 18, or over the age of 70. Strong sources of electromagnetic interference (EMI) can result in serious injury, system damage, or operational changes to the system. Strong sources of EMI include MRI, electrocautery, radiofrequency (RF)/microwave ablation, external defibrillators, and theft detectors. Patients on anticoagulation therapy may be at a greater risk for post-operative complications. The system may be affected by or adversely affect other implantable devices such as cardiac pacemakers and cardioverters/defibrillators. The use of non-Medtronic components with this system may result in damage. Adverse events related to the system include infection, stomach wall penetration, migration/erosion of the neurostimulator, programming difficulty, undesirable change in stimulation, hemorrhage, hematoma, migration of the lead, abdominal pain, seroma, concomitant muscle stimulation, allergenic or immune system response to implanted materials, loss of therapeutic effect, and gastrointestinal complications including small bowel obstruction.

Humanitarian Device: 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. The effectiveness of this device for this use has not been demonstrated.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

January 10, 2006
UC200200227b EN NI4812b

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