The Minneapolis Star Tribune last month reported that a 2-year Medtronic review of some 3,647 Infuse patients in 2008 turned up about 1,000 adverse events that weren’t reported to the FDA until 2013.
That prompted Sens. Al Franken (D-Minn.) and Amy Klobuchar (D-Minn.) to look to both Medtronic and the FDA for an explanation of the 5-year delay. Yesterday the newspaper reported that Medtronic Spine president Douglas King sent each senator a letter seeking to cast light on the issue.
King blamed unclear patient injury reporting policies at Medtronic Spine, the lack of a master list of the unit’s clinical activities and the fact that the study was shut down without 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 read, according to the Star Tribune.
Back in April Medtronic acknowledged that results from the review were not properly archived or fully assessed for reportability to the FDA, but that once the data was located in 2013 it was promptly reported “to all appropriate regulatory bodies.” The data does not change the safety and efficacy for Infuse, the company said at the time.
Franken told the newspaper that he welcomed the Medtronic update, but still has questions.
“Ultimately, the fact that this could occur at 1 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,” he said.
Klobuchar, who met with FDA commissioner Dr. Robert Califf to discuss the Infuse situation, agreed.
“Medtronic and the FDA have both admitted to making mistakes in this case,” Klobuchar said in a statement to the Star Tribune. “It is critical that we all work together to examine current practices and identify needed improvements to guarantee adverse events are reported as quickly and efficiently as possible.”
The letters say that Medtronic tolled 82 “conditions” during the review of 3,647 patients’ medical charts, but because the conditions had already been shown in other studies, the chart review didn’t affect the risk profile for Infuse, according to the newspaper.
“Only 122 events, or less than 12% of the total number of the subsequently reported adverse events, were identified by the surgeons as possibly related to Infuse, and the majority of those events were considered to be moderate or mild in severity,” King wrote to Franken, admitting for the 1st time that the “overwhelming majority” of Infuse procedures in the review were off-label uses, the Star Tribune reported.