Here are five things to know:
1. From 2006 to 2008, Medtronic conducted a retrospective study of 3,647 Infuse patients. However, the company shut down the study without reporting more than 1,000 adverse events to the government within 30 days.
2. While Medtronic concedes it should have reported the information in a timelier manner, they say employees misfiled the reports. Medtronic reported the adverse events to the FDA more than five years later.
3. In his letter to Mr. Ishrak and Commissioner Califf, Sen. Franken said the misinformation may have altered the risk profile of the device, compromising patient safety.
4. Neither Medtronic nor the FDA have made the patient complication specifics public, but they did tell Star Tribune the adverse events in the study did not show new types of problems with Infuse.
5. A Medtronic spokesperson said the company is eager to discuss their response with Sen. Franken, and a FDA spokesperson said the agency would “respond directly to the senator.”
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