(Reuters) - Medtronic Plc has agreed to stop manufacturing and distributing its SynchroMed implantable drug pump, U.S. regulators said on Monday, a step toward resolving allegations that the company violated quality standards with the device which delivers pain medication to cancer patients and others.
Medtronic failed to correct problems that could lead to a patient receiving too much or too little medication, the U.S. Department of Justice said in a statement on Monday. The DOJ said the company will change its manufacturing process and will not be required to recall existing devices.
The medical device maker and two top executives agreed to terms of the consent decree with the U.S. Food and Drug Administration, the DOJ said. The agreement includes Medtronic Chief Executive Omar Ishrak and Thomas Tefft, head of the neuromodulation division that makes the pumps.
Medtronic noted that the consent order does not affect the pumps it makes to deliver diabetes treatments.
Medtronic, the world’s largest standalone medical device maker, has agreed to stop manufacturing and distributing the SynchroMed pumps except in extraordinary cases where a physician certifies the product is medically necessary for treatment.
The proposed consent decree also requires Medtronic to retain an expert to help the company correct the regulatory violations.
Medtronic said it is focused on implementing design changes to the pump and improving its neuromodulation quality system. The implanted pump sends pain medication directly to the fluid around the spinal cord.
The company said it is not required to retrieve any products currently in use, and patients using the system do not need to change their course of therapy or have the pump removed.
Medtronic does not disclose sales of individual product lines but said more than 230,000 patients have used the SynchroMed system since its introduction more than 25 years ago.
BMO Capital Markets analyst Joanne Wuensch estimated the SynchroMed pump generated $204 million in U.S. sales last year.
The problems involving the pump were uncovered between 2006 and 2013 during FDA inspections at the company’s Columbia Heights, Minnesota, plant, the DOJ said. Among the violations were problems with design controls and complaint handling.
The DOJ filed a complaint and the consent decree in U.S. district court in Minnesota, which must approve the agreement.
Reporting by Susan Kelly in Chicago; Editing by Ted Botha and David Gregorio