Patient Section
This web page is available to help you understand Enterra Therapy
(gastric electrical stimulation). If you have questions and cannot
find the answers herein, or if any unusual situations or problems
arise, consult your doctor. Your doctor knows your personal medical
history and can give you the information that you may need.
The Enterra Therapy System
Enterra Therapy uses mild electrical pulses to stimulate the nerves and smooth
muscles of the lower stomach. This helps to control the chronic nausea and vomiting
associated with gastroparesis. The Enterra Therapy System components consist of:
 A small, battery-powered neurostimulator (about the size of a pocket watch;
2.4 inches long, 2.2 inches high, 0.4 inches thick), implanted beneath the skin
in the lower abdominal region- Two leads (insulated wires), implanted in the muscle wall of the stomach that are
connected to the neurostimulator
- A handheld, external clinician programmer, used by your doctor to adjust the
settings of your neurostimulator for customized therapy; your doctor can also
turn your therapy on and off with the programmer at any time without surgery
 Enterra Therapy received humanitarian
device exemption (HDE) approval from
the U.S. Food and Drug Administration
(FDA) in 2000. HDE status allows
Medtronic, Inc. to provide the Enterra
Therapy System for the treatment of
drug-refractory nausea and vomiting
associated with gastroparesis of diabetic
or idiopathic origin. Because of the HDE
status, the system must be implanted
in a medical center whose institutional
review board (IRB) has approved use of
the device.
Enterra Therapy System Implant
Implanting an Enterra Therapy System typically takes from 1 to 2 hours under
general anesthesia. Your doctor will discuss the surgery with you in detail and
determine the best locations for incisions and placement of the neurostimulator and
leads based on your medical history, individual anatomy, and personal preferences.
Your doctor will try to place the system in an area that is most comfortable for
you so that you can maintain normal daily activities. The location should also be
cosmetically acceptable to you. In addition, your doctor will follow special implant
and programming considerations if you have another medical device already
implanted.
Based on your doctor’s preference, one of two surgical techniques will be used
for your Enterra Therapy implant:
- Laparotomy “open approach”– surgery is performed through a small
abdominal incision, or
- Laparoscopy – special surgical instruments are inserted through tiny
incisions to perform the procedure
During the implant, the electrode at the tip of each lead is placed in the muscle wall
of your stomach. The lead bodies are then routed under your skin from the stomach
to the neurostimulator and connected.
The neurostimulator and leads are placed in a pocket formed just beneath your skin,
usually below the rib cage and above the belt line in the lower abdominal region.
The pocket is then sutured closed.
After the surgery, your doctor will use the clinician programmer to adjust the
neurostimulator to settings that will achieve the best possible symptom control
for you. Programming is noninvasive, painless, and can be done in the hospital
or doctor’s office.
Implanting an Enterra Therapy System has risks similar to any surgical procedure,
including infection, discomfort, or bruising.
Your doctor is the best person to answer any questions you have about the surgery.
Surgical Risks/Complications/Side Effects
The Enterra Therapy System should not be implanted in patients who are not candidates
for surgical procedures and/or anesthesia because of physical or mental conditions.
Implanting a neurostimulator system carries the same risks associated with any
other gastric surgery. Potential risks and complications may include, but are not
limited to:
Risks of Surgery
Implanting the neurostimulation system carries the same risks
associated with any other gastric surgery. Risks may include:
- Infection
- Allergic response to implanted materials
- Temporary or permanent neurologic complications
- Pain at the surgery site
- Bruising at the neurostimulator site
- Bleeding
Possible Side Effects
Side effects of neurostimulation of the stomach may include the following:
- Gastrointestinal (GI) symptoms
- Abdominal pain
- Feeding tube complications
- Difficulty swallowing
- Dehydration
- Acute diabetic complications
- Loss of therapeutic affect
Possible Device Complications
- There may be pain, lack of healing, or infection where the neurostimulation
system parts are implanted.
- The neurostimulation system parts may wear through your skin which
can cause an infection or scarring.
- The Enterra Therapy System could stop because of mechanical or electrical
problems. Either of these would require surgery.
- Your body may have an allergic reaction to the neurostimulation system.
- Your body could also reject the system (as a foreign body).
- The lead may perforate your stomach requiring surgery.
- There is the possibility of tissue damage resulting from the stimulation settings or a malfunction of one of the parts of the neurostimulation system.
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Site last updated on November 13, 2007
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