UPDATE 1-Medtronic gets FDA warning over plant issues
(Adds details from letter, share movement)
CHICAGO, July 17 (Reuters) - U.S. regulators sent medical device company Medtronic Inc. (MDT.N) a warning letter related to quality issues at a Minneapolis plant that makes implantable drug infusion and nerve stimulation devices.
Medtronic failed to submit timely reports on adverse events "after becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury," according to a July 3 letter to the company, posted on the U.S. Food and Drug Administration's Web site on Tuesday.
Many of those reports involve an inflammatory mass or granuloma, developing near the tip of a catheter used with the company's SynchroMed pump, which the FDA said is reportable as a serious injury.
A spokesperson for Medtronic was not immediately available for comment.
The seven-page letter also cites medical literature detailing potential problems with the company's products, that the company did not properly report to the agency.
"These articles included among other things, information on pump malfunctions, catheter separation or fracture and inflammatory masses and granulomas," the letter said.
The FDA issues dozens of warning letters to manufacturers each year. While most are resolved without further action, the agency can impose penalties or hold up product approvals if problems persist.
Medtronic shares were down 25 cents, or 0.46 percent, at $52.23 in morning trading on the NYSE.
((Reporting by Kim Dixon and Susan Kelly, editing by Maureen Bavdek; Reuters Messaging; kim.dixon.reuters.com@reuters.net; e-mail; kim.dixon@reuters.com, 1-312 408 8561)) Keywords: MEDTRONIC FDA/
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