The Food and Drug Administration has filed a court order against medical device giant Medtronic over repeated problems with its implantable drug pumps that went uncorrected for years.
Under the order, Medtronic must halt most production and distribution of its Synchromed II drug pumps, which are implanted devices used to treat patients with cancer, chronic pain and severe muscle spasms.
"The FDA expects that all patients will be treated with safe, effective and high-quality medical devices," said Jan Welch, a director in the agency's center for medical device regulation.
The FDA issued the company three warning letters about quality control and manufacturing problems at its drug pump facility in Columbia Heights, Minnesota between 2006 and 2013. FDA inspectors visited the plant five times over that period, the agency said in a Monday statement.
Among other defects, some Synchromed pumps had to be recalled because they could lose battery power and fail, endangering patients. In other cases, the devices could cause patients to receive too much or too little medication. Medtronic generally did not recommend that patients have the devices removed, unless they were proven to be failing.
The FDA's consent decree was filed in the U.S. District Court of Minnesota. The document alleges that Medtronic, CEO Omar Ishrak and neuromodulation business chief, Thomas Tefft, sold medical devices that failed to meet federally-enforced manufacturing standards. The company is also legally required to hire an outside expert to help correct the problems.
A consent decree is a form of legal settlement, in which a company agrees to certain court-ordered actions without admitting fault or guilt. The decree will remain in effect until the FDA determines Medtronic has fixed the problems outlined in the document.
Medtronic said the agreement allows the company to make some drug pumps available to physicians on a limited basis. The Minneapolis-based company stressed it is not announcing any new recalls or safety alerts about its products.
"Patients with the Synchromed drug infusion system do not need to change their current course of therapy, have the pump removed, or take any other action as a result of this agreement," Medtronic said in a statement.
Medtronic plc is the world's largest medical device company, specializing in implantable pacemakers, defibrillators, drug pumps and other medical equipment. Last year the company completed a $43 billion acquisition of Ireland's Covidien. The company now has its executive offices in Dublin, where it benefits from Ireland's lower corporate tax rates.
The settlement was announced concurrently by the FDA and the U.S. Justice Department.
