U.S. Senator Al Franken asked federal regulators and Medtronic Inc for detailed information about injuries associated with the company’s bone graft Infuse following a newspaper report that Medtronic hid thousands of adverse events linked to the product.
The Minneapolis Star Tribune reported on Sunday that Medtronic studied the outcomes of 3,600 patients who received Infuse between 2002, when the product was approved, and 2006. Doctors reported more than 1,000 adverse events.
But, instead of reporting the events to the U.S. Food and Drug Administration, within 30 days of discovering them, as required by law, Medtronic hid them, the Star Tribune said.
Medtronic officials told the Star Tribune that the database of adverse events was misfiled internally and was reported to the FDA after it was rediscovered more than five years later. It said no patients were hurt by the delay.
Medtronic’s operational headquarters is in Minneapolis.
Franken, a senator from Minnesota, asked Medtronic to clarify what information it gave the FDA and when. He also asked for information about how staff are trained to report adverse events and more details on the nature of the previously unsubmitted data.
Medtronic said in an email it had received Franken’s letter and looked forward to discussing the issues with him. It said the newpspaper’s claims were “false.”
In an extensive response to the article published by the Star Tribune on Monday, Medtronic said that once it discovered the study in 2013, it concluded that the adverse event data “were consistent with those already known across a wide body of literature and clinical study.”
Franken asked FDA Commissioner Dr. Robert Califf to provide more detail on the range of injuries captured in the previously unsubmitted adverse event data.
He also asked what proportion of the injuries were related to approved versus unapproved uses of the product. Franken also asked whether the apparently high rate of injury was consistent with other data the agency had on the product before it received the unsubmitted adverse event data.
“Your agency’s mission is to protect patients, first and foremost,” Franken wrote. The article, he wrote, “suggests that we need a strong commitment from the FDA, companies, and Congress to revamp medical device surveillance in this country with a focus on improving patient safety.”
A spokeswoman for the FDA, Angela Stark, said the agency had received the letter and would respond directly to Franken.