Officials with Medtronic have agreed to stop manufacturing, designing, and distributing their SynchroMed II pump systems except in extraordinary cases, such as when a treating physician certifies that a SynchroMed II pump is medically necessary for an individual patient’s treatment, under the terms of a consent decree reached this week.
According to a press release from the Department of Justice, the proposed consent decree also requires Medtronic officials to retain an expert to help address what they termed “regulatory violations,” which they stated the FDA observed, and could, they said, have resulted in “an over- or under-infusion of medication for patients.” Medtronic will not resume distributing the SynchroMed II pump system until it receives permission from the FDA.
In a statement Medtronic plc officials said they will be contacting physicians to ensure they have information about the agreement and the steps the company will be taking to continue to provide access to the SynchroMed drug infusion system. They device delivers pain medication to patients with cancer.
“The company’s efforts are focused on the implementation of design changes to the SynchroMed drug infusion pump to address issues the company has previously communicated, and on enhancing the Neuromodulation quality system,” according to the statement. “The agreement also includes a defined process by which Medtronic can continue to provide physicians with access to the SynchroMed drug infusion system for patients.”
Patients with the SynchroMed drug infusion system do not need to change their current course of therapy, have the pump removed, or take any other action as a result of this agreement.
This action is not related to Medtronic insulin pumps for diabetes. Additionally, the consent decree does not include any Medtronic businesses other than Neuromodulation.