Important safety information for patients

Indications: The Enterra^® Therapy System for Gastric Electrical Stimulation (GES) is indicated for the treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis. Patients should be carefully selected to assure that their symptoms are of physiological origin. Also, patients must be appropriate candidates for surgery. Contraindications: Diathermy can result in severe injury or death. If you are implanted with an Enterra or Enterra II system you should not receive magnetic resonance imaging (MRI).

Warnings and Precautions: It is not known if the system is safe and effective for pregnant women, for patients under the age of 18, or patients over the age of 70. Strong sources of electromagnetic interference (EMI) can result in serious injury, system damage, or changes to therapy delivery. The system may be affected by or adversely affect cardiac devices, electrocautery, defibrillators, ultrasonic equipment, radiofrequency (RF)/microwave ablation, radiation therapy, MRI and theft detectors/screening devices. You should avoid activities that may put undue stress on the implanted system (activities that include sudden, excessive, or repetitive bending, twisting, bouncing, or stretching that can cause damage to the implanted system). Adverse events: Adverse events related to the therapy, device, or procedure can include infection, pain at the surgery site, device components may wear through the skin, bruising at the neurostimulator site, bleeding, loss of therapeutic effect, undesirable change in stimulation (described as a jolting, shocking or burning sensation). The system could stop because of mechanical or electrical problems. The lead can become entangled with the bowel and cause life-threatening blockage or infections that require immediate medical attention. Any of these situations may require additional surgery or cause your symptoms to return. For further information, please see the patient manual and discuss the risks and benefits with your physician. For use by healthcare professionals only.

Disclaimer: This page may include information about products that may not be available in your region or country. Please consult the approved indications for use. Content on specific Enterra Medical products is not intended for users in markets that do not have authorization for use.