WASHINGTON – 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.
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Under the order, Medtronic must halt virtually all production and distribution of its Synchromed II drug pumps, used to treat patients with cancer, chronic pain and severe muscle spasms.
The FDA issued the company three warning letters about quality control and manufacturing problems at its drug pump manufacturing facility between 2006 and 2013. Among other defects, some devices had to be recalled because they could lose battery power, endangering patients.
The FDA's consent decree was filed in the U.S. District Court of Minnesota. The order names Medtronic CEO Omar Ishrak and an executive, Thomas Tefft, who heads the company's neuromodulation business.