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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.
By installing or using the Licensed Software or clicking any acceptance button in connection with this Agreement, you acknowledge, understand, agree to, and consent to all of the following, including when you are an Active Remoter User:
) 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.
) Your Personal Information. Medtronic will collect information in connection with your registration and installation and use of the Licensed Software, including your first and last name, your email address, a selected security question(s) and your corresponding answer(s), your address, and your telephone number. You agree that Medtronic may store this personal information about you on a Medtronic server, including a server located in the United States of America.
) 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.
Permissions. By installing and using the Licensed Software, you represent that you have permission to do so from any associated clinic, hospital, or medical practice and that your use of the Licensed Software complies with any policies or requirements of such associated clinic, hospital, or medical practice. You are also responsible for confirming that the Programmer User has obtained any necessary patient consent before allowing you to view any patient information via the Licensed Software.
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.
Reporting Issues and Feedback. You agree that you will report any issues or questions, technical or otherwise, regarding the Licensed Software promptly and directly to Medtronic. If you submit any comments or ideas to Medtronic, in the absence of a separate agreement regarding such submissions, you grant to Medtronic an unrestricted, royalty-free, irrevocable license to use, reproduce, display, perform, modify, transmit, and distribute such ideas in any medium and agree that Medtronic is free to use them for any purpose. In addition, Medtronic has no obligation to provide continued maintenance and support to you in connection with the Licensed Software. Any maintenance and support services provided by Medtronic shall be at Medtronic’s sole discretion.
Limitations of Liability.
THE LICENSED SOFTWARE IS PROVIDED TO YOU “AS IS,” AND MEDTRONIC EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES WITH RESPECT TO THE LICENSED SOFTWARE AND YOUR USE THEREOF, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, AND NONINFRINGEMENT. MEDTRONIC DOES NOT WARRANT THAT THE USE OF THE LICENSED SOFTWARE WILL BE UNINTERRUPTED OR ERROR-FREE.
Legal Compliance. You shall at all times use the Licensed Software in compliance with all applicable laws. You shall ensure that your installation and use of the Licensed Software complies with all applicable export and import laws, regulations, orders, and policies of the United States of America and any other applicable jurisdiction. You represent and warrant that (i) you are not located in a country that is subject to a U.S. Government embargo, or that has been designated by the U.S. Government as a “terrorist supporting” country, and (ii) you are not listed on any U.S. Government list of prohibited or restricted parties.
Term, Termination, Modifications, and Support. This Agreement shall be in effect from the date when you first install or use the Licensed Software. Medtronic may modify, amend, or terminate this Agreement at any time, including by providing notices or an updated version of this Agreement on a Medtronic website. Medtronic may modify, disable, or terminate your use or Medtronic’s support of the Licensed Software at any time, including by providing notices on a Medtronic website. All obligations which are ongoing in nature shall survive termination or expiration of this Agreement. At any time upon Medtronic’s request (including via a notice on a Medtronic website), you agree to promptly delete and terminate use of any and all copies of the Licensed Software. In addition, upon Medtronic’s request, you agree to provide written verification that you have destroyed all copies of the Licensed Software together with the manner, date, and time of such destruction.
NayaMed International Sárl Customers: Whether the RemoteView feature shall be used in connection with NayaMed customers or devices shall be solely within the discretion of NayaMed International Sárl. If the Licensed Software is used connection with NayaMed customers or devices, this Agreement shall be directly between you and NayaMed with respect to those uses.
Medtronic is proud of our long history and tradition of providing high-quality, innovative healthcare products and services. For nearly 70 years, Medtronic has been working to improve the lives of patients around the world. Along the way, we have been consistently recognized as one of the most admired and reputable companies in the world. Our reputation is the result of our commitment to patient safety, transparency, compliance, and ethical business practices.
Safety is our first and foremost priority, and we adhere to the highest medical, scientific, regulatory and legal standards. We regularly hear from patients and their physicians, recounting how our innovative therapies have dramatically improved health and saved lives. In an overwhelming majority of instances, our products perform exactly as intended, and the overwhelming majority of our 86,000 employees serve our customers every day with care, honesty, and integrity. When we communicate about our therapies and offerings, we strive for utmost accuracy, context and safety because we know that people will make life-impacting decisions based on those communications.
As a global healthcare company, we stand behind our products and embrace our responsibility as a leader in innovative, responsible and ethical development of life-saving medical technologies. Every day, we strive to meet and exceed our high standards of excellence in pursuit of our mission to alleviate pain, restore health and extend life.
Medtronic Statement Dated November 30, 2018
MEDTRONIC STATEMENT ON MEDIA COVERAGE CONCERNING THE COMPANY’S BUSINESS CONDUCT
Medtronic is aware of recent media coverage, advanced principally by the International Consortium of Investigative Journalists (ICIJ) and ICIJ-affiliated journalists, that calls into question the company’s ethics and business practices. The articles point to people and events that are associated with unethical conduct and then attempt to assert the entire company is, in and of itself, unethical.
Medtronic strongly rejects this assertion. Medtronic has more than 86,000 employees worldwide and many thousands of independent distributors, partners, contractors and suppliers that engage with or represent the company in an ethical manner every day. The company has instituted a variety of global compliance and ethics programs to ensure these employees and affiliated partners operate with the utmost integrity – in full compliance with Tenet 3 of the Medtronic Mission which states that we strive to be “recognized as a company of dedication, honesty, integrity and service.”
Q: It has been alleged that Medtronic’s business model is to develop a product and get it to market as quickly as possible. Do you dispute this characterization?
A: That is not accurate. At Medtronic, safety is our first and foremost priority and we reject any suggestion that Medtronic puts “innovation and profits” over safety. While we want to bring new, potentially life-saving therapies to patients as soon as possible, Medtronic will not offer a device or therapy to patients unless and until we have confirmed that the safety and efficacy profile is favorable in the context of the medical condition at issue and that we meet all of the appropriate regulatory requirements applicable in that market.
The process of medical device development, testing, and evaluation for safety and effectiveness is a highly developed scientific field. As a leading company developing new technology that extends patients’ lives, improves their health, and alleviates their pain, Medtronic has deep expertise in the testing and evaluation of new technology.
Our work in this area is overseen by leading regulators such as the FDA and its counterparts in other countries around the world. These agencies also employ thousands of leading scientists, and they draw upon the expertise of independent scientific and medical experts. These officials review our risk analyses, our test plans and study designs, and they evaluate the results of our analyses. They oversee our work to monitor products that have been approved and are in the market, and they audit our facilities and management processes.
Each new technology, or each update or improvement to an existing technology, requires an evaluation plan based on that specific product, and what is new or changed and what risks may be incurred in its use. Regulatory agencies oversee, guide, and audit our decisions in all of these areas. Getting these processes right and ensuring the safety and effectiveness of our products is the core of our business. For this reason, Medtronic employs 86,000 employees, including scientists, clinical research personnel, and regulatory and quality experts, and, during the past ten years, Medtronic has spent more than $10 billion on research and development.
Q: What does Medtronic do to ensure that its products are safe and effective before bringing them to market?
A: Medtronic has a large team of dedicated professionals – including physicians, scientists and engineers – whose first and foremost priority is to ensure that all our medical devices and therapies meet the highest safety, efficacy, and performance standards. During development, our products are rigorously tested to ensure that they are safe. Because our devices and therapies are complex and innovative, before coming to market, we often seek advice from outside experts and regulators, including the FDA.
Our products are also subject to extensive testing, evaluation, and clearance or approval by FDA and other regulatory agencies. As of the end of July 2018, we have 317 active Medtronic-sponsored clinical studies. These include concept, feasibility, verification, and biocompatibility studies, as well as clinical trials. Medical experts at the FDA and other regulators examine the results of these studies, as well as other data, before clearing or approving our products for use by doctors and patients. Last year alone, Medtronic invested $2.25 billion developing and testing new devices and therapies, and that number is expected to grow in 2018. In addition to pre-market clinical testing, Medtronic is an industry leader in post-market study and surveillance, during which we monitor, track, report on, and communicate with our regulators regarding safety and efficacy signals that emerge from “real world” experience with many of our products after they have been cleared and are being used by physicians and patients around the globe.
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.