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Receiving an Enterra® System

Getting ready for your Enterra System

If you and your doctor have decided that Enterra Therapy is right for you, this page will give you an idea of what to expect before, during and after your implantation procedure.

Is Enterra Therapy right for you? Answer a few questions to find out.

What to expect before, during, and after your Enterra procedure

Before surgery, your doctor will explain the implantation procedure in detail.

Before your procedure

Before surgery, your doctor will explain the implantation procedure in detail. Be sure to ask questions and share any concerns you or your loved ones may have.

Together, you and your doctor will discuss the best locations for incisions and placement of the Enterra System Neurostimulator and leads based on your medical history, individual anatomy, and personal preferences.

Your doctor will try to place your Enterra System in an area that’s comfortable and cosmetically acceptable to you.

During your procedure

Implanting the Enterra System typically takes from 1 to 2 hours under general anesthesia. 

Your doctor will choose one of two surgical techniques to implant the Enterra System, based on personal preference and your medical needs: 

  1. Laparotomy or “open approach,” in which surgery is performed through a small abdominal incision, or 
  2. Laparoscopy, in which special surgical instruments are inserted through small incisions

During surgery, the electrode at the tip of each lead is placed in the wall of your stomach muscles. The neurostimulator is placed in a pocket just beneath your skin, usually below the rib cage and above the belt line in the lower abdominal region. The leads are connected to the neurostimulator, and the pocket is sutured closed. 

There are risks related to the surgical procedure (including infection, discomfort, or bruising) as well as the therapy and devices. For more information, review the probable benefits and risks.

After your procedure

After you receive your Enterra System, your doctor will use the external clinician programmer to customize the level of stimulation that’s right for you. Programming is noninvasive and can be done in the hospital or in your doctor’s office. If you have another implanted medical device, your doctor will follow special programming considerations.

Frequently asked questions

Will people be able to see that I have a neurostimulator?

Your doctor will try to put the Enterra® II Neurostimulator in a place that is cosmetically acceptable and most comfortable for you when sitting, standing, etc. However, depending on your build, the neurostimulator may be noticeable as a small bump under the skin.

What does the stimulation feel like?

Most people report they do not feel the stimulation. Call your doctor if you notice any long-lasting pulsating, uncomfortable stimulation, or both, in your abdominal area.

Will gastric electrical stimulation limit my normal activities?

Generally, no. However, depending upon where the neurostimulator is placed, the device may hinder sharp bending of the body. Please discuss your physical activities with your doctor and ask how they may affect your neurostimulator.

Can a microwave, cordless phone, or cellphone interfere with my neurostimulator?

It is unlikely to affect the operation of the neurostimulator, but do keep at least 4 inches between them and the neurostimulator.

Will I encounter problems when I pass through security screening devices and theft detectors?

When approaching security screening devices and theft detectors in airports, stores, libraries, and other public buildings, request to bypass these devices if at all possible. They may interfere with your neurostimulator function or detect its metal case.

Always carry your EnterraTM device registration card with you and present it to security staff to obtain clearance. If they use a handheld security wand, ask them to move the wand over the neurostimulator as quickly as possible.

Point out the location of your neurostimulator so that testing can be performed quickly. If you must pass through the security screening device or theft detector, follow these precautions:

  • If the security gate has two sides, simply walk through the center of the gate, keeping as far away as possible from each side
  • If a security device has only one side, walk as far away as possible from it
  • Do not linger near or lean on a theft detector or security screening device
How often should my doctor check the neurostimulator?

A typical follow-up schedule often includes office visits at 1 week after surgery; 1, 3, and 6 months after the surgery; and then every 6 to 12 months. However, your doctor may want to see you more or less often, depending on your situation.

How is the neurostimulator replaced?

When the battery in your neurostimulator runs down, your doctor will obtain prior authorization from your insurance company and approval for a replacement surgery. Then he or she will schedule a surgical procedure for you. The doctor will remove the neurostimulator and implant a new one.

During the surgery, the doctor should also check your implanted leads to make sure they are working properly. If they are, the new neurostimulator will be connected to the leads that are already in place. If the leads are not working as they should be, they will be replaced too.

Whom should I contact in case I have a problem?

Your first call should always be to your doctor. Call your doctor if you have questions or problems concerning your device or medical condition.

When should I contact my doctor?

Contact your doctor if any of the following events occur:

  • You have pain, redness, or swelling at the incision later than 6 weeks after surgery.
  • You have new or unusual abdominal pain, cramping, nausea, or vomiting at any time after surgery.
  • You are experiencing an increase in your nausea or vomiting. The neurostimulator may simply require readjustment to a different therapy setting, or there could be a problem with the lead or neurostimulator. Your doctor should be able to determine the cause of the problem and correct it.
Is gastric electrical stimulation covered by insurance?

Many health insurance companies cover costs associated with gastric electrical stimulation. Be sure your doctor requests prior authorization and coverage from your insurance company before the implant. He or she will explain your gastroparesis* symptoms and gastric electrical stimulation to the insurance company. You may also need to personally communicate with your insurance company.

The information provided on this site is for general educational purposes only and is not a substitute for professional medical advice, diagnosis or treatment. Always talk to your doctor about the best treatment options for your individual situation.

MKT-D-0003, Rev T

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.

*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 in patients aged 18 to 70 years. The effectiveness of this device for this use has not been demonstrated. What does this mean?