FDA Files Consent Decree Against Medical Device Manufacturer

Repeated failings to correct violations related to the manufacturing of a medical device has led the FDA to file a consent decree against Medtronic, Inc, and 2 of its officers today.

The decree prohibits the Synchromed II Implantable Infusion Pump Systems, which deliver medication for primary or metastatic cancer, chronic pain, and severe spasticity, from being manufactured and distributed. However, exceptions may be made in instances where a physician believes the system is medically necessary for a patient’s treatment.

According to the FDA, S. Omar Ishrak and Thomas M. Tefft’s product, which was manufactured in Columbia Heights, Minnesota, does not follow quality system regulations for medical devices that ensure safe use.

Back in 2006, the FDA noted that there were problems with the pumps that could lead to over- or under-infusion or a delay in therapy for patients.

Medtronic received 3 letters of warning surrounding the violations, following 5 inspections between 2006 and 2013, the FDA noted. The FDA investigators pointed to problems with identifying and correcting quality problems, plus failure to document design changes, and a failure to ensure that the final products met design specifications.

“The FDA expects that all patients will be treated with safe, effective, and high-quality medical devices,” Jan Welch, acting director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health, said in a press release. “We will continue to stop distribution of devices made by firms that fall short of regulatory requirements.”

Medtronic will have to seek a third-party expert to create a plan to correct violations, and the consent decree will stay in effect until the company has met certain provisions. In addition, when Medtronic begins to distribute the products again, it must submit audit reports to the FDA, and the agency will continue to monitor the company via inspections.

The FDA press release advised patients that they should contact their physician if they experience a change or a return in symptoms or if they hear a device alarm.