FDA filed a consent decree against Medtronic, CEO Omar Ishrak and Thomas Tefft, SVP and president of the neuromodulation unit at the company for “repeatedly failing to correct violations” that occurred at Medtronic’s neuromodulation facilities in Columbia Heights, Minnesota involving the manufacture of Synchromed II Implantable Infusion Pump Systems.
As a result of the decree, which cites violations in the QSR, Medtronic is required to stop manufacturing, designing and distributing Synchromed II infusion pumps and cannot resume such activity until it receives permission from FDA. The company must also retain a third-party expert to assist in developing and submitting plans to correct the violations.
“The FDA expects that all patients will be treated with safe, effective and high-quality medical devices,” said Jan Welch, acting director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health in an agency release. “We will continue to stop distribution of devices made by firms that fall short of regulatory requirements.”
Between 2006 and 2013, Medtronic received three warning letters following inspections conducted at the facilities. The company was cited for major violations: “inadequate processes for identifying, investigating, and correcting quality problems with the Synchromed II Implantable Infusion Pump Systems; failure to document design changes; and failure to ensure that finished products meet design specifications,” according to FDA.