Medtronic failed to report to FDA more than 1000 adverse events related to its controversial Infuse bone graft device between 2006 and 2008, according to a report in the Star Tribune of Minneapolis.
Company employees discovered the adverse events—including four deaths—in a retrospective chart review of Infuse, but shut down the study in spring 2008 without reporting them to FDA, the Star Tribune said. Most of those employees have since left the company, leaving current officials befuddled by the failure to report.
