Failure To Report Infuse Data Was Unintentional, Says Medtronic

The president of Medtronic’s spine business told Minnesota’s two U.S. senators this week that no one ever intended to hide a study of the company’s controversial Infuse product that went unreported for years.

Letters to Sens. Al Franken and Amy Klobuchar from Medtronic Spine President Douglas King revealed new details of the study, which the Star Tribune first reported April 10. After the article appeared, Franken and Klobuchar each asked for explanations of how the world’s largest medical device company misplaced a study of 3,647 Infuse patient records that revealed 1,045 “adverse events.”

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