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Important safety information for healthcare providers

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. 

Intended clinical benefit

The intended clinical benefit of Enterra Therapy is to reduce chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis. 

Patient selection

Select patients carefully to ensure that: 

  • Their symptoms are of physiological origin. 
  • They are appropriate candidates for surgery. 

Contraindications

The Enterra Therapy System is contraindicated in patients whose doctor determines are not candidates for surgical procedures and/or anesthesia due to physical or mental conditions. After implantation of any system component, the following contraindications apply: 

  • Diathermy – Do not use shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy on patients implanted with a neurostimulation system. 
  • 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). 
  • Shelf Life – The Model 37800 IPG must be implanted within 18 months from date of manufacturer. The Model 4351-35 Lead must be implanted within 24 months from date of manufacturer. 

Warnings

Use as indicated and instructed – Read all information available for the system. Only use products for the indicated therapy and indicated populations. Bowel obstruction/perforation – The lead can become entangled with or erode into the bowel, which can result in bowel obstruction and perforation. Gastric erosion/perforation – The lead(s) can erode through the stomach wall and result in gastric perforation with possible lead migration into the lumen of the intestine. Patients may experience high lead impedance measurements, decreased therapeutic effect, increased nausea, vomiting, abdominal pain, life threatening intra-abdominal infections and gastrointestinal obstruction that may require laparotomy and/or system revision or removal. Electromagnetic Interference (EMI) – Electromagnetic interference is a field of energy generated by equipment found in the home, work, medical or public environments that is strong enough to interfere with gastric stimulator function. 

Precautions

The safety and effectiveness of this therapy have not been established for: 

  • Pregnancy, unborn fetus, or delivery. 
  • Pediatric use (patients under the age of 18). 
  • Patients over the age of 70. 

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. Any of these situations may require additional surgery or cause your symptoms to return. 

For full instructions for use please consult the IFU at https://www.enterramedical.com/intl-hcp/manuals/. For use by healthcare professionals only.