Updated on 29 April 2015
The violations occurred at the company's neuromodulation facilities in Minnesota
Singapore: US Food and Drug Administration has filed a consent decree against Medtronic and its senior officers Mr S Omar Ishrak and Mr Thomas M Tefft, for repeatedly failing to correct violations, related to the manufacture of Synchromed II Implantable Infusion Pump Systems, medical devices that deliver medication to treat primary or metastatic cancer, chronic pain and severe spasticity.
The legal action requires the company to stop manufacturing, designing and distributing new Synchromed II Implantable Infusion Pump Systems except in very limited cases, such as when a physician determines that the Synchromed II Implantable Infusion Pump System is medically necessary for a patient's treatment.
FDA stated that the violations occurred at the company's neuromodulation facilities in Columbia Heights, Minnesota, where the devices are manufactured.
The consent decree cites violations of the quality system regulation for medical devices, which requires manufacturers to have processes in place to assure that the design, manufacture and distribution of a device allows for its safe use.
The consent decree also requires Medtronic to retain a third-party expert to help develop and submit plans to the FDA to correct violations. The consent decree will remain in effect until the FDA has determined that Medtronic has met all the provisions listed in the consent decree.