Paula's Story DBS THERAPY FOR DYSTONIA
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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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) Registration. To obtain access to the Licensed Software, you must register at the Medtronic RemoteView website and establish a user name and password. All information that you provide in connection with such registration must be complete, accurate, and truthful. The user name and password are personal to you and must not be shared with anyone else. You will also not attempt, directly or indirectly, to disable, bypass, or defeat any password protection associated with the Licensed Software. Medtronic reserves the right to deny or disable any user name or password or request for any user name or password.
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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.
) Logging of Session Activity. Each time you log in to the Licensed Software, Medtronic will collect information about your activity, including in an aggregated log or database, regarding you and your session, including your name, username, computer name, IP address, operating system details, and session details (including transferring and sharing activity, start and end times, view only or control activity, and any chat messages between or among any Active Remote Viewers. You agree that Medtronic may store any personal information about you on a Medtronic server, including a server located in the United States of America.
) 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.
) Availability. Medtronic has limitations on the number of users that can concurrently log in to the Licensed Software at any given time. Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time.
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Your Acknowledgements. You acknowledge that the Licensed Software is not the exclusive method of viewing information from the Programmer and that the Licensed Software is not the exclusive method by which to obtain a patient’s implanted cardiac device data, including any data on the Programmer. You also acknowledge that the Licensed Software is not intended to be used as a life-sustaining or interventional tool during medical emergencies. You further acknowledge that Medtronic is not, and shall not be deemed to be, a provider of patient health care services by virtue of its provision of access to the Programmer screen information via the Licensed Software. You also acknowledge that information from the Licensed Software is not an electronic medical record and use of the Licensed Software does not in any way relieve you from using your best medical judgment to determine a proper course of treatment for patients.
Security/Privacy of Patient Data. Your use of the Licensed Software and any Session Keys shall be solely for legitimate and lawful purposes and not for any malicious purpose. You are solely responsible for and will use your best efforts in maintaining the confidentiality and security of any copies of the Licensed Software as well as any user name, password credentials, and any Session Keys that can be used in accessing the Licensed Software, a Medtronic server, or any information from a Programmer. You are solely responsible for and will use your best efforts in keeping any patient information you may receive or view in connection with the Licensed Software confidential and secure, and you will not attempt to capture or copy any patient information you view in any electronic or hard copy format without the express permission of the Programmer User. You will be responsible for any obligations or liabilities associated with any lost, stolen, or otherwise compromised patient information.
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This story recounts the experience of one individual who is receiving Medtronic DBS Therapy to manage symptoms of dystonia.* Please bear in mind that the experiences are specific to this particular person.
In 1988, Paula's physical pain started to affect her professional relationships and her career. Her colleagues at the radio station where she worked couldn't understand what was happening to the enthusiastic and vivacious woman they once knew and admired.
Paula was in a great deal of pain. She couldn't sit down or walk for more than a few minutes at a time. She tried everything to cope with the disabling pain and disfigurement she later learned was the result of dystonia.
Dystonia is a neurological movement disorder that causes involuntary muscle contractions. These contractions force certain parts of the body into abnormal, repetitive, twisting, and sometimes painful movements or postures.
Eventually, Paula was forced to quit her job. Embarrassed by her appearance, Paula stopped venturing outside of her home. She became depressed, and worried that she would never again be able to do the things she loved, like playing with her nieces and nephews, working, and traveling.
Paula tried various treatments to cope with the disease. She started regimens of oral medications and injection treatments. At one point, Paula received up to 20 shots of Botox® every few months. At first, these treatments helped stabilize her symptoms, but her situation had gotten "out of control," as she recalls.
On the advice of her neurologist, Paula decided to have treatment with DBS Therapy.
After the procedure, Paula spent time reorienting herself to her own body. "I'm still amazed that I can actually pick up objects with my hands," she says. "Before DBS, my body did whatever it wanted. I had no control over it."
It took time for Paula to get used to the neurostimulator that was placed under the skin in her upper chest area. "For about six months, when I would turn side to side, there was a slight delay in the movement of the device. Then, tissue settled in around it and now I don't feel it at all when I move."
Since her first surgery, Paula has had the neurostimulator battery replaced several times. After her most recent replacement, her stimulation settings were lowered. Now, her battery is lasting about 26 months as compared to 14 months at the higher settings.
After each replacement surgery, Paula has experienced some soreness and swelling at the incision site.
Placing the DBS system requires brain surgery, which could have serious and even fatal complications including coma, bleeding inside the brain, stroke, seizures, and infection. Once implanted, the system may become infected, parts may wear through the skin, and the lead and/or extension connector may move. Medtronic DBS Therapy could stop suddenly because of mechanical or electrical problems. Any of these situations may require additional surgery or cause symptoms to return or worsen, which may be life-threatening. Medtronic DBS Therapy may cause new or worsening neurological or psychiatric symptoms.
In patients receiving Medtronic DBS Therapy, depression, suicidal thoughts, and suicide have been reported.
For more information, go to Important Safety Information.
Today, Paula lives on her own and maintains an active lifestyle. She can cook, exercise and meet friends for dinner – all activities she had to put on hold due to dystonia. "Most people can't believe that I'm the same person," says Paula. "I'm just thrilled to have my life back."
Not everyone who receives Medtronic DBS Therapy will receive the same results as the individual in this story; some people may experience significant symptom relief from DBS Therapy, and others may experience minimal symptom relief. Talk to your doctor to determine if Medtronic DBS Therapy is right for you. A prescription is required.
BOTOX® is a registered trademark of Allergan, Inc.
Information on this site should not be used as a substitute for talking with your doctor. Always talk with your doctor about diagnosis and treatment information.
Humanitarian Device - Authorized by Federal Law as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis), in patients seven years of age or above. The effectiveness of the devices for treating these conditions has not been demonstrated.
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