Karen's Story Enterra Therapy
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Medtronic, Inc. (“Medtronic”) offers RemoteView, which permits a user (“Programmer User”) of the Medtronic CareLink® 2090 Programmer (“Programmer”) to allow the viewing of information presently displayed on the Programmer screen with one or more individuals in remote locations anywhere in the world (“Remote Viewer”), including remote health care professionals or Medtronic representatives.
Limited License Grant. You are hereby granted a nonexclusive, nontransferable, terminable, nonassignable, nonsublicensable, limited license to install and use a copy of the Licensed Software solely for authorized and legitimate purposes. You may not otherwise copy, use, modify, reverse engineer, decompile, disassemble, create derivative works based on, or integrate with other systems or programs the Licensed Software without the prior written consent of Medtronic. You shall have sole responsibility for any fees or charges, including service or data charges, incurred by you in connection with your use of the Licensed Software. You shall not remove any proprietary or other legend or restrictive notice contained or included in the Licensed Software or other documentation associated with such Licensed Software. You agree to maintain any and all copyright, trademark, and other notices on the Licensed Software and any associated documentation.
Licensed Software Functionality and Data Use, Collection, Viewing, and Transfer.
“Active Remote Viewer” as referred to herein shall mean a Remote Viewer that has installed the Licensed Software and has at the relevant point in time an active network connection to a Medtronic server via the Licensed Software.
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) Session Key. To view the information on the Programmer, the Remote Viewer must generate a Session Key that must be shared with and entered by the Programmer User. “Session Key” as used herein means a unique token active for a limited period of time generated by the Remote Viewer. You agree not to share this Session Key with anyone other than the Programmer User who has initiated the specific session.
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) Active Remote Users. When you are an Active Remote Viewer: (1) you will be able to view the name and/or user name of any other Active Remote Viewer who is logged into the same Medtronic server; and (2) any other Active Remote Viewer who is actively logged into the same Medtronic server will be able to view your name and/or user name. The Licensed Software also permits one Active Remote Viewer to share the information being viewed to any other Active Remote Viewer. You must not share any information from the Medtronic programmer, including with any other Active Remote Viewer, absent the express permission from the Programmer User that is allowing you to view the information.
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This story recounts the experience of one person who is receiving Enterra™ Therapy (gastric electrical stimulation). Medtronic invited her to share her story candidly. Please bear in mind that the experiences are specific to this particular person. Not everyone who receives Enterra Therapy will receive the same results as the person in this story.
Karen, a 47-year-old mother of three, loves to participate in activities with her large extended family – from school events to church functions to birthday celebrations. In fact, her family often depends on her to plan and organize multi-generational gatherings.
In late 2001, however, complications from Karen's diabetes led to gastroparesis*, a condition characterized by chronic nausea and vomiting. The condition left Karen bedridden.
"The nausea was so bad, day and night, that I had to stop all activities," Karen recalls. "I could not sit up or converse with people. I couldn’t even cry about it, because crying made me feel sicker. A simple activity like watching television became impossible."
Karen tried prescription and over-the-counter drugs in search of relief, but nothing helped. Behavioral therapy and breathing techniques failed too.
"I could never be far from a bathroom," explains Karen. "My diet consisted of a little yogurt, crackers, and a food supplement. Occasionally, I sucked on a lemon to relieve the nausea."
After a year of symptoms, Karen met with a team of physicians whose testing indicated that gastric electrical stimulation might relieve her chronic nausea and vomiting symptoms.
"I was thrilled to have an option that might give me my life back," Karen says. "The gastric emptying test and endoscopy before the implant were tolerable compared to other procedures I’ve had. In fact, the only discomfort I felt was my chronic nausea."
Unfortunately, Karen’s excitement met with a major obstacle. Her healthcare insurance company considered neurostimulators to be experimental devices, and wouldn’t cover it under her plan. With support from her physicians and family, Karen won her fight to gain reimbursement for the implant after an 18-month delay.
Karen underwent a procedure for a neurostimulator in 2004. While the effectiveness of gastric electrical stimulation hasn’t been shown, and results differ for each patient, it has helped Karen. "Since receiving Enterra Therapy, I’ve gone from focusing on coping with my gastroparesis to living a regular life," she says.
"I was able to eat a normal diet again and participate in family activities, including our regular cook-outs," Karen says. "One of my greatest thrills was being able to eat a hamburger again."
Karen credits her family for bolstering her courage, and her physicians for teaching her how to care for herself properly. "If I still run into problems, it’s because I’ve made poor dietary decisions," she explains.
"Ultimately, the responsibility of what goes into your stomach lies with you."
Surgical complications are possible and may include infection, bleeding, bruising, and pain at the implant site. Once implanted, the system may become infected, devices may move or wear through the skin, the lead may perforate the stomach, the lead may entangle with or obstruct the bowel, irritation/inflammation over implant site may occur. The therapy system could stop suddenly because of mechanical or electrical problems. Any of these situations may require additional surgery or cause your symptoms to return and some can be life-threatening.
For a list of adverse events that have been associated with the therapy, please refer to Important Safety Information.
*Humanitarian Device: The Enterra Therapy system for gastric electrical stimulation is authorized by Federal law for use in treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology. The effectiveness of this device for this use has not been demonstrated. What does this mean?
This story reflects one person's experience. Not every person will receive the same results. Talk to your doctor about your treatment options.
Disclaimer: This page may include information about products that may not be available in your region or country. Please consult the approved indications for use. Content on specific Medtronic products is not intended for users in markets that do not have authorization for use.