Medtronic Enters Consent Decree for Safety Violations
FDA enters consent decree with Medtronic, Inc.
On April 27, 2015, the Food and Drug Administration (“FDA”) announced its filing of a consent decree against Medtronic, Inc. and two of the company’s officers, S. Omar Ishrak and Thomas M. Tefft for repeatedly failing to correct safety violations related to the Sychromed II Implantable Infusion Pump Systems. FDA News Release
The pump systems are medical devices that deliver medication to treat primary or metastatic cancer, chronic pain, and severe spasticity.
The consent decree cites ongoing violations between 2006 through 2013. During that time, FDA investigators conducted five inspections and issued three warning letters for violations including “inadequate processes for identifying, investigating, and correcting quality problems,” “failure to document design changes”, and “failure to ensure that finished products meet design specifications.” The consent decree will remain in effect until the FDA has determined that Medtronic has met all the provisions listed in the consent decree.
If you or a loved one suffered injuries that you believe were caused by a Medtronic Sychromed Infusion Pump, contact one of the experienced attorneys at Burg Simpson today. Our award-winning lawyers would be happy to discuss your potential claim. Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today.