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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.
The SynchroMed II drug pump is a battery-powered implantable and programable device that stores and dispenses medication inside the body. The pump delivers the medicine to the fluid around the spine through a thin, flexible tube called a catheter. A doctor programs the pump to release a certain amount of medication. Both the amount and timing can be adjusted as to the patient’s needs change. The device can be used to treat chronic pain conditions, including cancer-related pain, and to manage severe spasticity of spinal origin (e.g., spinal cord trauma or multiple sclerosis) or cerebral origin (e.g., cerebral palsy).
In 1988, FDA first approved SynchroMed as a Class III medical device for the infusion of drugs to palliatively treat certain types of cancer, pursuant to FDA’s Premarket Approval (PMA) process, the agency’s most stringent medical device review process. The SynchroMed II device was approved in 2003 under the same guidelines. The SynchroMed II device can be used to treat chronic pain conditions, including cancer-related pain, and to manage severe spasticity.
The PMA process is the most stringent medical device marketing review process in the United States. It is estimated that FDA spends an average of 1,200 hours reviewing each PMA application.1 FDA grants premarket approval for Class III devices only if it finds there is sufficient valid scientific evidence to show that the device meets the appropriate risk/benefit ratio for its intended use.
Medtronic continues to monitor the safety of SynchroMed II. In addition to mandated reporting of adverse events to the MAUDE database, Medtronic analyzes occurrence of all adverse events reported to us. Medtronic’s broad scale Product Performance Registry is another source of data that demonstrates reliability of the system and identifies safety improvements for the device.
In 2004, Medtronic initiated an FDA-approved 12-month, multi-center, single arm prospective post-approval study for SynchroMed II to determine flow-rate accuracy and safety over 12 months. Medtronic submitted and received FDA approval for labeling updates based on this study. The final safety findings were also published in a medical journal, Regional Anesthesia and Pain Medicine. The authors concluded, “the SynchroMed II pump accurately and safely delivered intrathecal medications in the clinical setting of this study.”2
Additionally, we’re currently running another post-approval study in Europe. Medtronic also maintains a Product Performance Registry where it posts annual reports monitoring the performance of its products. This prospective, long-term multi-center registry contains insights collected from more than 7,400 targeted drug delivery system patients at 60 centers worldwide who were enrolled between August 7, 2003 through July 31, 2016, and collection of this data continues. The Registry is used to monitor and investigate performance and adverse event trends and to collect and analyze data that drives product enhancement and innovations.
Medtronic continues to improve the design and performance of the SynchroMed II pump. Three durable design changes and one software change were implemented in 2016 and 2017. Medtronic continues introducing new innovations in drug infusion technology. In January, 2018 we announced FDA approval of a new tablet-based clinician programmer to simplify therapy management by providing physicians with visual tools and intuitive workflows. On July 31, 2018, FDA approved a new SynchroMed II myPTM™ Personal Therapy Manager for patients with chronic pain. myPTM works with SynchroMed II drug pump and further allows patients to personalize their therapy to alleviate unpredictable pain. “Pain is very personal and can be unpredictable,” said John A. Hatheway, M.D., owner and provider at Northwest Pain Care in Spokane, Washington. “The Medtronic pain pump and myPTM are powerful tools to safely treat chronic pain including intractable cancer pain."
Medtronic continues to meet its obligations under the U.S. consent decree related to the SynchroMed II system. Since early 2016, we’ve implemented a series of design changes to the SynchroMed II system intended to increase performance and safety, including improvements aimed at reducing motor stalls and the potential for over-delivery of drug in the initial 24 hours of therapy.
We’ve also made improvements across our Quality Management System (QMS), resulting in achieving substantial compliance noted through a series of inspections by an independent expert and FDA.
The previous requirements for obtaining certificates of medical necessity prior to distributing the SynchroMed II system were lifted in the U.S. in Fall 2017 and have been lifted in all countries outside the U.S. as well. This was an important milestone that allowed access to patients who depend on Intrathecal drug delivery as an option for the treatment of chronic, intractable pain or severe spasticity.
Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)
Wesemann K, Coffey RJ, Wallace MS, Tan Y, Broste S, Buvanendran A. Clinical accuracy and safety using the SynchroMed™ II intrathecal drug infusion pump. Reg Anesth Pain Med. 2014; 39:341-346.
IMPORTANT SAFETY INFORMATION
SynchroMed II Drug Infusion System Brief Statement
Product technical manuals and the appropriate drug labeling must be reviewed prior to use for detailed disclosure.
Indications: US: Chronic intrathecal infusion of Infumorph® preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain, Prialt® chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain, and chronic intrathecal infusion of Lioresal® Intrathecal (baclofen injection) for the management of severe spasticity. Outside of US: Chronic infusion of drugs or fluids tested as compatible and listed in the product labeling.
Drug Information: Refer to appropriate drug labeling for indications, contraindications, warnings, precautions, dosage and administration, screening procedures, and under-/overdose symptoms and methods of management. Patients should be informed of the signs and symptoms of drug under- or overdose, appropriate drug warnings and precautions, and signs and symptoms that require medical attention.
Contraindications: System implant is contraindicated in the presence of an infection; implant depth greater than 2.5 cm below skin; insufficient body size; and spinal anomalies. Use of the system with drugs with preservatives and drug formulations with pH ≤3. Use of CAP kit for refills or of refill kit for catheter access and use of PTM to administer opioid to opioid-naïve patients or to administer ziconotide.
Warnings: Non-indicated formulations may contain neurotoxic preservatives, antimicrobials, or antioxidants, or may be incompatible with and damage the system. Failure to comply with all product instructions, including use of drugs or fluids not indicated for use with system, or of questionable sterility or quality, or use of non-Medtronic components or inappropriate kits, can result in improper use, technical errors, increased risks to patient, tissue damage, damage to the system requiring revision or replacement, and/or change in therapy, and may result in additional surgical procedures, a return of underlying symptoms, and/or a clinically significant or fatal drug under- or overdose.
An inflammatory mass that can result in serious neurological impairment, including paralysis, may occur at the tip of the implanted catheter. Clinicians should monitor patients carefully for any new neurological signs or symptoms, change in underlying symptoms, or need for rapid dose escalation. Monitor patients appropriately after refill if a pocket fill is suspected. Failure to recognize signs and symptoms of pocket fill and seek appropriate medical intervention can result in serious injury or death. Overinfusion may lead to underdose or overdose symptoms. Strong sources of electromagnetic interference (EMI), can negatively interact with the pump and cause heating of the implanted pump, system damage, or changes in pump operation or flow rate, that can result in patient injury from tissue heating, additional surgical procedures, a return of underlying symptoms, and/or a clinically significant or fatal drug underdose or overdose. The SynchroMed II system is MR Conditional; consult the labeling for MRI information.
Precautions: Monitor patients after pump or catheter replacement for signs of underdose/overdose. Infuse preservative-free saline at minimum flow rate if therapy is discontinued for an extended period of time to avoid system damage. EMI may interfere with programmer telemetry during pump programming sessions. EMI from the SynchroMed programmer may interfere with other active implanted devices (e.g., pacemaker, defibrillator, neurostimulator).
Adverse Events: In addition to procedure-related risks, the following may occur: pocket seroma; hematoma; erosion; infection; pump inversion; post-lumbar puncture risks (spinal headache); CSF leak and rare central nervous system pressure-related problems; radiculitis; arachnoiditis; spinal cord bleeding/damage; meningitis; neurological impairment (including paralysis) due to inflammatory mass; allergic response to implant materials; surgical replacement due to end of service life or component failure; loss of therapy, drug overdose, or inability to program the pump due to component failure; catheter complications resulting in tissue damage or loss of or change in therapy; potential serious adverse effects from catheter fragments in intrathecal space.
For full prescribing information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic's website at www.medtronic.com.
Infumorph® is a registered trademark of West-Ward Pharmaceutical. Prialt® is a registered trademark of Jazz Pharmaceuticals plc or its subsidiaries. Lioresal® is a registered trademark of Saol.
USA Rx Only
Medtronic has notified physicians about product advisories related to Medtronic Targeted Drug Delivery Systems. This information can be found at medtronic.com.
We are committed to answering your questions, keeping you informed, and continuously improving our products. If you have questions about the advisories, please contact Medtronic Patient Services at 800-510-6735, Monday through Friday, between 8 am and 5 pm, CT.
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.
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.