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FDA Orders Medtronic to Halt Sales of SynchroMed Drug Pumps

Medtronic Plc, the world's third largest medical device company,  agreed to stop manufacturing and distributing its SynchroMed II implantable drug pumps last week. The U.S. Food and Drug Administration filed a court order against Medtronic ordering this halt in production due to violations of quality standards with the device and years of uncorrected problems.

The SynchroMed drug pumps are used to treat patients with cancer, chronic pain, and severe muscle spasms. They are surgically implanted and generate a drug solution in the area surrounding the spinal cord. Generally, these drug pumps are prescribed for patients who do not respond to oral medications or who experience severe side effects when taking them.

Along with other defects, some SynchroMed pumps had to be recalled because they could lose battery power and fail, which was dangerous for patients. Additionally, Medtronic failed to correct problems that could lead to a patient receiving too much or too little medication, the U.S. Department of Justice said in a statement last Monday.

"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," Medtronic said in a statement.

The agreement does, however, allow Medtronic to manufacture some drug pumps available on a limited basis to physicians.

Visit our Defective Drug & Medical Device page to learn more about such claims.