This informed consent template is an optional tool for your site to use in preparing an
informed consent if your IRB requires it. Medtronic and the FDA do not require an
informed consent for the HDE.
Please do not list Medtronic as the sponsor in this informed consent, and do not send
this informed consent to Medtronic for approval. This is not a Medtronic research
study.
Enterra Therapy Informed Consent Template
HDE Number:
H990014
Physician: <add site specific information>
Phone Number: <add site specific information>
Contact Person: <add site specific information>
Phone Number: <add site specific information>
Introduction
Gastroparesis is a condition that involves problems emptying the stomach. Some symptoms are vomiting,
nausea, the feeling of being full right away when you start eating, and abdominal pain. Gastroparesis may
also lead to malnutrition and weight loss.
Current treatment for gastroparesis generally includes drugs. Two frequently used types of drugs are called
prokinetics and antiemetics. Prokinetic drugs are used to speed the emptying of your stomach. Antiemetic
drugs are used to help decrease your symptoms of vomiting and nausea.
This information is provided to you to help you make an informed decision about another treatment option,
the Enterra Therapy Gastric Stimulation System. It’s also to help you understand more about this treatment
and how it differs from other treatments you may have tried. Enterra Therapy is indicated for the treatment
of patients with long term, uncontrolled (not helped by medication) nausea and vomiting from gastroparesis
of diabetic or idiopathic (unknown) origin.
This form may contain words that you do not understand. Please ask the doctor or his staff to explain any
words or information that you do not clearly understand. You may take home an unsigned copy of this
consent form to think about or discuss with family or friends before making your decision about this
treatment option.
Definition of a Humanitarian Use Device
In March of 2000, the Food and Drug Administration (FDA) gave approval of a Humanitarian Device
Exemption (HDE) of a Humanitarian Use Device (HUD) for Enterra Therapy to Medtronic, Inc.
Humanitarian use devices are medical devices approved by the FDA for the treatment of medical conditions
affecting fewer than 4,000 patients per year. In granting HDE approval for a humanitarian use device, the
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Page 1 of 9
This informed consent template is an optional tool for your site to use in preparing an
informed consent if your IRB requires it. Medtronic and the FDA do not require an
informed consent for the HDE.
Please do not list Medtronic as the sponsor in this informed consent, and do not send
this informed consent to Medtronic for approval. This is not a Medtronic research
study.
FDA focuses primarily on the safety of the device, rather than how well it helps. Although there is evidence
that suggests the use of the Enterra Therapy probably helps patients’ symptoms, the FDA’s HDE approval
indicates that the helpfulness of this therapy has not been proven.
You are not being asked to participate in a research study. Because of the type of approval given by the
FDA, each hospital’s Institutional Review Board decides if you should receive this written information
about this therapy.
Description of the Medical Devices
The Enterra Therapy system consists of a neurostimulator (device), two leads, and an external programmer.

A neurostimulator is an implantable device that produces electrical pulses to stimulate your stomach.
The device is about 2 ½” x 2”x 1/2” and is surgically placed under the skin in the abdomen. It
contains an electrical circuit that your doctor programs as to how often stimulation is delivered to the
stomach and how strong the pulse should be to improve the symptoms of gastroparesis. Both the
battery and the electronic circuit are enclosed in a titanium housing. How long the battery lasts
depends on the rate and strength of stimulation and how often the settings are changed. At low output
settings, the battery may last five years or more. At higher settings, the battery may last about one year
or up to five years. When the battery wears out, the device can be replaced in a minor surgical
procedure.

The leads are implantable thin wires with an electrode at the tip. The leads carry the electrical
energy from the device to the stomach muscle. One end of each lead is placed in the muscle wall of
the stomach, and the other end connects to the device.

Your doctor will use an external programmer to change the settings of the device. Part of the
programmer is held outside the body over the implant site and can adjust or change the settings of
the device using radio remote control.
Evaluating Who Should Receive This Therapy
Enterra Therapy is indicated for the treatment of patients with long term, uncontrolled (not helped by
medication) nausea and vomiting from gastroparesis of diabetic or idiopathic (unknown) origin.
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Form MEDN-3432 version 2.0
Page 2 of 9
This informed consent template is an optional tool for your site to use in preparing an
informed consent if your IRB requires it. Medtronic and the FDA do not require an
informed consent for the HDE.
Please do not list Medtronic as the sponsor in this informed consent, and do not send
this informed consent to Medtronic for approval. This is not a Medtronic research
study.
When the Device Should Not Be Used (Contraindications)
Patients Not Candidates for Surgery
The Enterra Therapy System is not allowed in patients whom the doctor determines are not candidates for
surgical procedures and/or anesthesia due to physical or mental conditions.
Diathermy
Implantation of an Enterra Therapy System is absolutely not allowed under any circumstances because the
risk outweighs the benefits for patients exposed to diathermy. Inform anyone treating you that you
CANNOT have any shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (also
known as deep heat treatment) anywhere on your body because you have an implanted neurostimulation
system. Energy from diathermy can be transferred through your implanted system, can cause tissue damage
and can result in severe injury or death. Diathermy can also damage parts of your system. This can result in
loss of therapy from your system, and may require additional surgery to remove or replace parts of your
implanted system. Injury or damage can occur during diathermy treatment whether your system is turned
“ON” or “OFF.”
Implant Procedure
The implant of the device and leads requires surgery and general anesthesia (you will be asleep and will not
feel or hear anything). The surgery takes about one to three hours. One end of each lead will be placed in the
muscle of the middle part of your stomach and the other end of each lead will be connected to the device.
The device is placed under the skin of the abdomen in a “pocket” made by the surgeon. An exam of the
inside of your stomach with an endoscope (flexible tube with a light and camera attached to it) will be done
during the implant. This helps the surgeon find the site where the leads should be attached to your stomach.
It also helps decrease the risk of the lead making a hole in the stomach. X-rays may be taken after surgery
to check the position of the leads and device. Your doctor will decide how long you will stay in the hospital
after the implant based on your medical condition.
Follow Up Schedule
Your doctor will want to see you for follow up visits after surgery. < please insert your specific follow up
schedule for your patients and what will happen at the follow up visits> You should be followed by a
doctor for as long as you have this system.
Potential Risks/Side Effects
Electromagnetic Interference (EMI)
EMI is a field of energy (electric, magnetic or a combination of both) generated by equipment found in the
home, work, medical or public environments that is strong enough to affect the function of your device.
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Page 3 of 9
This informed consent template is an optional tool for your site to use in preparing an
informed consent if your IRB requires it. Medtronic and the FDA do not require an
informed consent for the HDE.
Please do not list Medtronic as the sponsor in this informed consent, and do not send
this informed consent to Medtronic for approval. This is not a Medtronic research
study.
The device has features that protect the device from EMI. Most electrical devices and magnets found in a
normal day are not likely to affect the function of the device. Strong sources of EMI can result in:
 Serious injury or death, resulting from heating of the devices, which can damage tissue
around the device or leads.
 System damage, requiring surgical replacement, or resulting in a loss of or change in
symptom control.
 Device settings changing causing the device to switch on or off, or to reset to default factory
settings. This may cause a loss of stimulation and return of symptoms. In that case, you may
need to see your doctor to reprogram the device.
Magnetic Resonance Imaging (MRI)
Use of MRI may cause system failure, dislodgement, heating, or may cause uncomfortable “jolting” or
“shocking” levels of stimulation. If you are asked to have an MRI taken, you must have your doctor contact
either Medtronic at 1-800-328-0810 or contact the doctor who placed your Enterra Therapy device. Failure to
follow proper precautions concerning MRI could result in serious injury or death.
Home, Public, and Occupational Environment
Most household appliances and equipment that are in good working order and properly grounded will not
interfere with your system. If you think that equipment is interfering with your system, move away from it or if
possible, turn the equipment or object off. Tell the equipment owner/operator about what happened. If you
think that your therapy is not working after being around some equipment, contact your doctor.
Theft Detectors and Screening Devices
Be careful when approaching theft detector and security screening devices (such as those found in airports,
libraries, and some department stores). It is possible that you may feel a brief increase in the stimulation as you
pass through a screening device. Some patients have described this as uncomfortable, “jolting,” or “shocking.”
Some patients have even fallen down or been injured by such events. Some devices have not been able to be
programmed after the patient walked through a security device. If possible, ask to go around the device. Show
the security personnel your patient identification card and ask for a manual search. If you have to go through a
theft detector or screening device, try to stay as far from the security device as possible. If the security device
has two sides, walk through the center of the device. Walk through the security device normally. Do not linger
or lean against the screening device. Please note that some security screening devices are not visible to the
public.
Patient Activities
Patients should avoid activities that may put undue stress on the system. Activities that include sudden,
excessive, repetitive bending, twisting, bouncing, or stretching can cause the lead to break or dislodgement
of the devices.
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Page 4 of 9
This informed consent template is an optional tool for your site to use in preparing an
informed consent if your IRB requires it. Medtronic and the FDA do not require an
informed consent for the HDE.
Please do not list Medtronic as the sponsor in this informed consent, and do not send
this informed consent to Medtronic for approval. This is not a Medtronic research
study.
Patients should avoid rubbing or twisting the devices on purpose, as this can cause damage to the device,
skin erosion, or uncomfortable or painful stimulation at the implant site.
Patients should not dive below 33 ft. of water or enter hyperbaric chambers. This could cause damage to the
system. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure
with their doctor.
Components
The use of non-Medtronic components with this system may result in damage to Medtronic components,
loss of therapy, or patient injury.
Risks of Surgery
Implanting the neurostimulation system carries the same risks associated with any other gastric surgery.
Some of the risks of surgery include: infection, allergic response to implanted materials, temporary or
permanent neurologic complications, pain at the surgery site, bruising at the neurostimulator site, or
bleeding.
General Anesthesia
There are always risks with general anesthesia. These may include a reaction to the drugs you receive, heart
attack, or even death. A tube will be placed through your mouth into your windpipe to help you breathe
while you receive general anesthesia. Risks from this tube include infection, or a hole or tear in your
windpipe. You may have a sore throat or hoarseness after your surgery. There may be other unknown risks.
Endoscopy
With any endoscopy there is the risk of making a hole or tear in the esophagus or stomach. You may have a
sore throat after your endoscopy.
Possible Side Effects
Possible side effects from the stimulation include:
 Gastrointestinal (GI) symptoms
 Undesirable change in stimulation
 Extra-abdominal, bone, or joint-related pain
 Feeding tube complications
 Difficulty swallowing
 Dehydration
 Acute diabetic complications
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Page 5 of 9
This informed consent template is an optional tool for your site to use in preparing an
informed consent if your IRB requires it. Medtronic and the FDA do not require an
informed consent for the HDE.
Please do not list Medtronic as the sponsor in this informed consent, and do not send
this informed consent to Medtronic for approval. This is not a Medtronic research
study.




Loss of therapeutic affect
Abdominal muscle stimulation
Fever
Stress incontinence
Possible Device Complications
 The Enterra Therapy system could stop because of mechanical or electrical problems. Either
of those would require 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.
Interference with other implanted devices
This system may interfere with other implanted devices, such as a defibrillator or pacemaker. External
defibrillators, electrocautery devices, radiation therapy, ultrasonic devices, psychotherapeutic procedures,
radio frequency (RF), and microwave ablation may interfere with the function of the system and may cause
some damage to it. The electrical signal from this system may interfere with the function of an external
defibrillator.
Make sure to inform your doctor if you currently have any implanted devices. After surgery, make sure you
inform any health care providers such as doctors or dentists that you have this implanted system.
Pregnancy risks
Safety for use during pregnancy or delivery has not been established. The side effects of Enterra Therapy
on an unborn child have not been determined. It is important that women of childbearing potential use some
type of birth control during this therapy. If you find that you are pregnant, you must inform your doctor as
soon as possible to discuss your options.
Risks of the System
The possible risks of this implanted system include:
 A broken lead
 The lead changing position
 The device not working
 The device moving and causing pain
 An infection at the site of the device or leads
 The leads causing a blockage in the intestines
 The lead making a hole in the stomach wall
 Swelling by the pocket or wound from surgery
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Page 6 of 9
This informed consent template is an optional tool for your site to use in preparing an
informed consent if your IRB requires it. Medtronic and the FDA do not require an
informed consent for the HDE.
Please do not list Medtronic as the sponsor in this informed consent, and do not send
this informed consent to Medtronic for approval. This is not a Medtronic research
study.



Failure of the wound from the surgery to heal
Allergic or immune system response to the implanted device and leads
The neurostimulation system parts may wear through your skin which can cause an infection
or scarring
If the site of the one or both of the leads becomes infected or does not work, then you will be treated with
antibiotics and the leads may have to be removed. This would require general anesthesia and surgery
similar to that performed to implant the leads. If one or both of the lead wires cause a blockage of the
intestine, it could require surgery to repair. If the site where your device is implanted becomes infected then
you may be treated with antibiotics. If the infection does not end or the device becomes defective, then it
may have to be removed or replaced in a minor surgical procedure. If you are taking blood-thinners, you
may be at greater risk for problems after surgery such as swelling, bleeding, or bruising.
There is always a potential risk of human error in programming the device. Stimulation at high rates and
strengths might be painful and cause tissue damage. If you feel pain while having the device programmed, you
should inform your doctor immediately so he or she can check the device settings.
There is a risk that the stimulation might not help you. It could even cause pain or worsen your problem. In the
event that any of these problems occur, you can tell your doctor of the problem and he or she can turn the
device off. The devices could be removed in a surgical procedure if you choose or if your doctor recommends.
Your doctor may decide to leave some devices implanted, such as a portion of the leads, since removing
everything would involve a more complex procedure.
Your doctor will minimize these risks by careful assessment of your condition, cautious procedures during the
implant, and careful follow-up after the system has been implanted.
If your device is explanted for any reason, it will be returned to Medtronic for analysis.
Other Risks
There may be other risks that are unknown with this therapy. Your doctor and/or Medtronic will notify you if
any serious new risks become known. For this reason, it is very important to keep both your doctor and
Medtronic informed of any address changes.
If you have any questions about any of these risks please ask your doctor. Call your doctor if any of the
following events occur:
 You have pain, redness, or swelling at the surgery site longer than 6 weeks after surgery.
 You have new or unusual abdominal pain, cramping, nausea, or vomiting at any time after
surgery.
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Page 7 of 9
This informed consent template is an optional tool for your site to use in preparing an
informed consent if your IRB requires it. Medtronic and the FDA do not require an
informed consent for the HDE.
Please do not list Medtronic as the sponsor in this informed consent, and do not send
this informed consent to Medtronic for approval. This is not a Medtronic research
study.

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.
Potential Benefits
Potential benefits of this therapy may include decreased symptoms of your disease. You may be able to eat a
more normal diet, including solid foods. If your symptoms greatly improve, you may have a better quality
of life. However, this therapy does not work for everyone.
Age Limits
Safety and effectiveness of this system have not been established for patients under the age of 18 or over the
age of 70.
Alternative Therapies
Current treatment for this disease includes changes in your diet, drugs, and tube feedings. Your doctor can
discuss other types of treatment with you.
Costs
All costs related to this implant are your responsibility.
Voluntary Participation/Right to Withdrawal
You understand that receiving this therapy is voluntary. If you do decide to stop therapy, you are asked to
contact your doctor and inform him or her of your decision, and discuss options for alternative therapy.
Confidentiality
You understand that any information about you obtained during this therapy will be kept confidential and
your name will never be identified in any report or publication unless you sign a release. You also
understand that authorized representatives of the Institutional Review Board, and the Food and Drug
Administration (FDA) may examine your records, so absolute confidentiality cannot be guaranteed.
The manufacturer of Enterra Therapy, Medtronic, will not be collecting information on patients who receive
Enterra Therapy except that which is needed to provide you with an Implanted Device Identification Card
that you should carry with you at all times to confirm that you have an implanted device. If a patient who
received Enterra Therapy has an adverse event, information concerning the event will be reported to
Medtronic.
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Form MEDN-3432 version 2.0
Page 8 of 9
This informed consent template is an optional tool for your site to use in preparing an
informed consent if your IRB requires it. Medtronic and the FDA do not require an
informed consent for the HDE.
Please do not list Medtronic as the sponsor in this informed consent, and do not send
this informed consent to Medtronic for approval. This is not a Medtronic research
study.
An adverse event includes any problem with the device, and any reaction, side effect, injury, or sensitivity
related to the use of the device. If an adverse event should occur, information will be included on the report
to Medtronic. Medtronic may also receive information to assist you with your insurance issues. This
information may include your name, address, social security number, date of birth, insurance policy number,
hospital identification number, and hospital medical record number. This information may also include
your medical history and results of physical exams, laboratory tests, and procedures pertinent to the disease
process of Enterra Therapy.
Questions
Your doctor will answer any questions you have. If you have questions in the future, you may call your doctor
at <add site specific information>. He or she will be available to answer questions related to the therapy. A
physician, nurse or technician involved with this therapy may also be available. [May also include Medtronic
Patient Services contact info] If you would like to talk to someone other than your doctor, you may contact
<add site specific information>at your doctor’s Institutional Review Board at <add site specific
information>with questions.
Consent
I have read the information above. All procedures have been explained to my satisfaction, and my questions
have been answered. I understand that complications may arise or result during the procedures that are
performed at my request. I will be given a copy of this consent form after it has been signed to keep.
I voluntarily agree to have this therapy. I understand that I may withdraw from the therapy at any time I
choose. If I wish to discontinue my therapy, I may do so without penalty. My decision will not affect my
routine medical care by my doctor or treatment at this medical center. By signing this consent, I also agree to
follow all instructions and recommendations given to me by my doctor for my care.
_________________________________________
Patient’s Printed Name
_________________________________________ ________________
Patient’s Signature
Date
_________________
Time
_________________________________________
Patient’s Legally Authorized Representative
(when applicable)
_________________________________________
Person Obtaining Informed Consent’s Signature
________________
Date
_________________
Time
________________
Date
_________________
Time
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