Medtronic says failure to report Infuse data was unintentional

By and Star Tribune

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.”

 The company responded that the reporting problem happened because Medtronic Spine’s policies for reporting patient injuries in such a study were unclear, the department did not have a master list of its clinical activities, and the study was closed down without following a formal process.
“While we regret that events from the retrospective chart review were not reported earlier, we have no information to suggest the failure to report was intentional,” King’s letter to Franken says.


Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

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