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.
Medtronic has said previously that employees misfiled data from the study, without reporting adverse events to the Food and Drug Administration as the law required. The company reported the adverse events to the FDA more than five years later, but neither the company nor the agency has made full details public.
Franken said in a statement to the Star Tribune that he welcomed the additional information Medtronic provided. But he said he still has questions.
"Ultimately, the fact that this could occur at one of the world's leading medical device companies demonstrates that we need to improve the way we monitor the safety and efficacy of medical devices in the United States," Franken said.
Infuse is a synthetic human protein that causes bone growth after lower-back surgery, among other approved uses. It has spawned thousands of product liability complaints and sparked multiple government investigations.
