Description of Enterra Therapy or gastic pacemaker

Anne (AU) has one and has benefitted greatly.

• Enterra Therapy may reduce symptoms of nausea and vomiting for many people suffering from              gastroparesis when drugs are ineffective. The therapy is reversible and can be turned off at anytime.

Will the Enterra Therapy cure my stomach problems?

• This therapy is not a cure, but may be a beneficial treatment for your symptoms. How well it relieves symptoms varies from person to person.

What is an Enterra Therapy (Gastric Electrical Stimulation) System?
Enterra Therapy is prescribed by a physician. The Enterra Therapy system components include:

• An implanted neurostimulator that is usually surgically placed in the lower abdomen                  region.
• Two intramuscular leads (wires) with electrodes implanted in the muscle wall of your stomach.
• A programmer that the physician uses to control and adjust the settings of your implantedneurostimulator.

Risks and Probable Benefits of Enterra Therapy 

Enterra Therapy may reduce symptoms of nausea and vomiting for certain people suffering from
gastroparesis when drugs are ineffective. The therapy is reversible and can be turned off at any
time.

Results of clinical studies done on Enterra Therapy.
Enterra Therapy has been used successfully in people over several years. Enterra Stimulation is
approved for the treatment of nausea and vomiting from gastroparesis when drug treatments are
not effective.

A worldwide clinical trial was conducted with people who had severe symptoms of nausea and
vomiting associated with gastroparesis. Clinical trials are controlled studies carried out to
evaluate how well a therapy treats a condition and how safe it is. The study results help
government agencies (such as the FDA) decide whether to approve a device or therapy for
commercial use.

The interim results of the clinical trial (Medtronic FDA Application H990014) show that the
therapy successfully reduces symptoms of nausea and vomiting in patients for whom drug
treatments did not work. The average number of vomiting episodes before implant and at 6 and
12 months after surgery are shown in the chart.

Weekly Vomiting Frequency

•  100% of patients experienced a reduction of vomiting at 12 months following implant versus baseline.
• 93% of patients experienced a reduction of vomiting episodes greater than 50% at 12 months following implant vesus baseline.
• 53% of patients experienced a reduction of vomiting episodes greater than 80% at 12  months following implant versus baseline.
• 66% of patients experienced a reduction of vomiting to less than 7 episodes per week at 12 months following implant.

NOTE: (Medtronic FDA Application H990014)

The interim results of clinical studies indicate that Enterra Therapy may be a beneficial treatment
alternative for patients suffering from drug refractory gastroparesis of idiopathic or diabetic
etiology. Patients treated with Enterra Therapy had a significant reduction in vomiting frequency
at 6 and 12 months. Patients also experienced improvements in other upper gastrointestinal
symptoms, solid food intake, and a reduction in hypoglycemic attacks (diabetics), as well as
significant improvements in health related quality of life.
What problems did patients experience in this study?
The adverse events observed during the clinical evaluation of the Enterra Therapy system
include: lead impedance out of range, device infections, device erosion, device migration,
stomach wall perforation, upper gastro-intestinal (GI) symptoms, extra-abdominal pain, feeding
tube complications, lower GI symptoms, dehydration, bone- and joint-related pain, acute
diabetic complications, dysphagia, cardiovascular/renal related events, urinary tract infections,
stress incontinence, fever, and infections (sinus, pink eye, herpes zoster). These effects were
related to the device, implant, underlying disease, other therapies, or other.

Other potential complications which were not seen during clinical evaluation include: undesirable
change in stimulation, possibly related to cellular charges around the electrodes, shifts in
electrode position, loose electrical connections, or lead fractures; hemorrhage, hematoma, and
possible GI complications resulting from the surgical procedure to implant the neurostimulator
and leads; migration of lead or stimulator, which may necessitate surgical revision; persistent pain
at the neurostimulator site; seroma at the neurostimulator site; allergenic or immune system
response to implanted materials; and loss of therapeutic effect.

Enterra Therapy Surgery

Implantation of the Enterra Therapy system is a surgical procedure done under general
anesthesia. During this operation, your surgeon will implant two small electrodes in the muscle
wall of the stomach. The lead will then be connected to the implantable neurostimulator that is
placed beneath the skin, and usually positioned below the rib cage and above the belt line in your
abdomen. This operation may last from one to three hours. You should speak with your doctor
and/or surgeon beforehand so that you understand how the operation will be performed, what
the risks of surgery are, and what you should expect during your post-operative recovery.

NOTE: Cardiac pacemakers may be affected by the Enterra Therapy if the two systems are
too close to each other. Tell your doctor if you have a cardiac pacemaker so he or she can
assess any possible electrical interference problems and decide if you can also have Enterra
Therapy.

more on this subject

How to Deal with Medical Professionals (Effectively)

tips from Anne –  What to bring with you –SAMPLE

what to bring with you – I bring this…MRS ANNE JENNIFER PLEDGER D.O.B. 16/7/XX MEDICAL HISTORY The bearer has SHY-DRAGER SYNDROME –  (PAF), a disease of the autonomic central nervous system. Can under no circumstances be subjected to any magnetic field inc MRI. Main symptom – Severe postural hypotension. If Bearer faints- Lie flat, raise legs, no medication. See attached information about Shy-Drager Syndrome and PAF (Pure Autonomic Failure) Contracted Rheumatic Fever 1960. Antibiotics must be given BEFORE any invasive procedures/surgery/dentistry/tests. Gastric Pacemaker must be switched off by hand held device (in handbag) for procedures, surgery and scans. Scans etc. must not be taken over area of pacemaker. Has Nocturnal Epilepsy. In case of nocturnal attack administer extra 4 Rivotril. Contact: Mr A. Pledger Home 07 55328619, Mobile 0403 508062 Medic Alert bracelet worn on wrist. Emergency telephone number for medical history is engraved on the back. MEDICAL PRACTITIONERS Dr. Phillip Myer G.P . (07) 55394055 Dr. Paul Dinnen Vascular Surgeon (07) 55971877 Dr. James Clark Shy – Dragor Specialist (07) 55395566 Dr. Lloyd Dorrington Gastroenterologist (07) 55914455 Dr. Philip McDougall Urologist (07) 55323766 Dr. Matthew Scott-Young Orthopaedic Surgeon (07) 55286477 Dr. Bryan Farage Cardiologist (07) 55396716 Dr. John Corbett Neurologist (07) 55311699 Dr. John Kearney Eye Specialist (07) 55329099 Dr Robin Rowley Anaesthetist (07) 55323667 Dr Greg Falk Fitted Gastric Pacemaker (02) 97457444 MEDICATIONS Premarin 625mcg 1 tablet at night Rivotril 500mcg 1 tablet 3 times daily with meals, 4 tablets at night Dymadon 500mg 1 tablets four times a day Biquinate 300mg 1 tablet at night Endone 5mg 2 tablets 3 times daily ALLERGIES Scholine (Life support req.) Amitriptyline (Convulsions) Aspirin Trimethoprim Morphine (Severe vomiting) All Sulpha based Drugs All Stimulating Drugs i.e. Urecholine Phiseptone Xylocaine (Aerosol) (Throat swells) Tylenol Ephedrine (Stimulant) Anginine (Severe Headaches) History Appendectomy 1957                                            Multi Organ Failure = Kidney/Liver/Lung failure 1989 Manchester Repair X 7 1967                                 Femoral Extension Bypass   Sept 1991 Hysterectomy 1968                                              Angioplasty June 1993 Ulna Nerve Repositioning 1976                              Femoral Extension Bypass April 1994 Gall Bladder Removal 1978                                   Laminectomy  Sept 1994 Angioplasty (damaged arteries) 1984                    Carpel Tunnel Release  Nov 1995 FemoralBypass 1984                                           Laminectomy  July  1998 Iliac Bypass  1984                                               Laminectomy   Aug 1998 Coeliac Patch/S.M.A Bypass 1989                       L4/5 Spinal Fusion  Aug 1999 `                                                         GASTRIC Pace Maker Implant Dec 2001 GASTRIC Pace Maker implanted at Strathfield Private Hospital Sydney  by Dr Greg Falk -Hospital Medical File No 78240 Pindara Private Hospital – Hospital  Medical File No 7368