Feds compel Medtronic to sharply limit production of drug pump

(This article has been updated with a correction.)

Medtronic must drastically limit production and sales of its implantable infusion drug pump under a consent decree with federal regulators who say the company failed to ensure the product was safe.

The U.S. Justice Department filed a consent decree reached with Dublin-based Medtronic and its CEO Omar Ishrak and Senior Vice President Thomas Tefft. The government filed the agreement and a civil complaint Monday in U.S. District Court in Minnesota. Medtronic was based in Minneapolis before acquiring Dublin-based Covidien this year, and the company maintains its operational headquarters there.

The complaint alleges Ishrak and Tefft repeatedly failed to adequately address violations related to the production of Medtronic's Synchromed II Implantable Infusion Pump system after the Food and Drug Administration issued three warnings about the device between 2006 and 2013.

The FDA said Medtronic lacked adequate processes to track and correct quality problems with the devices and failed to document design changes and ensure products met design specifications.

“The proposed consent decree will require Medtronic and its leadership to commit to making changes in their process that will benefit the American public by ensuring that their products are safe and effective for patients,” Benjamin Mizer, principal deputy assistant attorney general of the Justice Department's Civil Division, said in a news release.

As part of the agreement, Medtronic must stop producing and distributing the device except in cases where a physician certifies that the pump is medically necessary. Medtronic will also be required retain an outside expert to help correct its violations. The company will be allowed to resume distribution of the pump only after it receives permission from the FDA.

The implantable pumps are used to inject pain medication into the spinal fluid for treatment of chronic, intractable pain, severe spasticity and cancer in cases where oral medications are not effective or carry bad side effects.

The FDA recommended patients who have already had the device implanted should maintain regular follow-up care and contact their physician if they experience any changes. The agency did not recommend that patients have the devices removed.

Medtronic said it would contact physicians to ensure they have information about the agreement and are aware of the steps the company will take to provide access to the SynchroMed drug infusion system.

"We are committed to the highest level of quality, and have pursued significant efforts in recent years to enhance the performance of the pump and to address the FDA's expectations," said Tefft, who serves as president of Medtronic's neuromodulation unit, in a statement. “We are confident that our efforts to date will contribute to the timely and thorough completion of these activities while preserving access to this important therapy in the interest of patients, their caregivers and physicians."

(This article has been updated to indicate that production and sales of the pump will be not halted entirely.)