Medtronic agrees to FDA deal over SynchroMed, neuromodulation system
By Brad Perriello
Medtronic says it agreed to the terms of a consent decree with the FDA over its SynchroMed drug-infusion pump and its neuromodulation quality system.
Medtronic (NYSE:MDT) said today that it agreed to terms on a consent decree with the FDA over its SynchroMed drug infusion pump and its neuromodulation quality system, seeking to resolve the problems that have plagued the SynchroMed intrathecal drug delivery device.
Fridley, Minn.-based Medtronic said the consent decree, which must still be approved by the federal court in nearby Minneapolis, “imposes certain restrictions on the company and outlines the steps it must take to address the FDA’s expectations.”
Regulators in jurisdictions including the U.S., the U.K. and Hong Kong have issued a series of warnings in recent years about the SynchroMed device, which is designed to deliver medication directly to the intrathecal space around the spinal cord. It’s indicated to treat chronic, intractable pain, severe spasticity and cancer, Medtronic said.