Patients and Caregivers
For additional information
Medtronic Patient Services
Information for Patients and Caregivers
Medtronic is committed to providing support and answering your questions
If you or someone who you care for has or is considering a SynchroMed drug delivery pump manufactured by Medtronic Neuromodulation, please read the following or contact us at 1-800-510-6735.
Medtronic has entered into an agreement with the U.S. Food and Drug Administration (FDA) called a consent decree. This agreement provides the FDA with expanded oversight of continued improvements to the SynchroMed pump and related quality processes. We are committed to supporting you and we want to provide information about this agreement and what it means to you.
If you currently have a SynchroMed pump, you do not need to change your current course of therapy or have the pump removed as a result of this agreement. Further, with the announcement of this agreement, there are no changes or other new information to communicate regarding the safety or performance of the SynchroMed pump.
Patient safety is our first priority. Medtronic conducts ongoing performance and reliability monitoring for our products, and we are confident that this pump continues to provide safe and effective therapy. As always, follow your physician’s instructions regarding managing and monitoring your therapy and contact him or her immediately if you notice any changes in your symptoms.
To speak with someone at Medtronic, please call our Patient Services Call Center at 1-800-510-6735.
Frequently Asked Questions
Do I need to have the SynchroMed drug delivery pump removed?
With this announcement, the agreement does not call for removal of the SynchroMed pump or recommend changes to the current use of the therapy. There is no new information to share about the safety and performance of the SynchroMed pump with this announcement.
What steps do patients have to take because of this announcement?
Patients do not need to take any action as a result of this announcement. Patients or caregivers who have any questions can call the Medtronic Patient Services Call Center at 1-800-510-6735.
Is the SynchroMed drug delivery pump safe?
Patient safety is our top priority. The SynchroMed pump continues to demonstrate strong overall performance, and we are confident in its ability to deliver safe and effective therapy. As always, patients should follow their physician’s instructions regarding managing and monitoring their therapy and contact them immediately if any changes in symptoms are noticed.
Medtronic SynchroMed drug delivery therapy is an important treatment option for patients with chronic pain, severe spasticity, or cancer who have not had success with other treatment options or who experience intolerable side effects with oral medications. Further, more than 500 published articles have referenced the SynchroMed pump, making it the world's most studied implantable infusion system.