The U.S. Food and Drug Administration (FDA) has filed 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 violations relating to the manufacture of Synchromed II Implantable Infusion Pump Systems. The agency announced the legal action against the medical device maker on Monday.
The Synchromed II Implantable Infusion Pump Systems deliver medication to treat primary or metastatic cancer, chronic pain and severe spasticity. The device was approved by the FDA in 2004, and problems with the manufacture of the systems came to light in 2006. These problems can result in over- or under-infusion or a delay in therapy for patients. The FDA said in a press release on the agency’s website that the violations occurred at Medtronic’s Neuromodulation facilities in Columbia Heights, Minnesota, where the Synchromed II Implantable Infusion Pump Systems are made. [Read more…]