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Medtronic warning letter

This article was originally published in The Gray Sheet

Executive Summary

Firm's Synchromed II and MiniMed Paradigm insulin pumps are subject to a June 1 FDA warning letter. During a Nov. 12-Dec. 15, 2008, inspection of Medtronic's Puerto Rico manufacturing facility, FDA identified quality system violations related to manufacture of the Synchromed devices and medical device reporting violations related to the Paradigm pumps. For example, Synchromed pumps were distributed and implanted in patients without being filled with a necessary propellant, but the firm took nearly two years to conduct a recall. In addition, Medtronic failed to report device-related serious injuries to FDA in a timely manner, the agency charges

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