Infuse is a synthetic human protein that spurs bone growth after spinal surgery, among other uses. The Medtronic product has been the center of multiple government investigations.
The study in question included data on 3,647 Infuse patients. Five years after Medtronic ended the study, the company reported the occurrence of 1,045 adverse events to the Food and Drug Administration. Medtronic previously stated that employees initially misfiled the data, according to the Tribune.
“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,” reads Mr. King’s letter to Sen. Franken, according to the Star Tribune.
Mr. Franken reportedly welcomed the additional information provided by Medtronic, but stated that there were still unanswered questions from the company and expressed concern regarding how the FDA handled the matter.
Mr. Franken told the Tribune, “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.”
Medtronic informed the Tribune that the company stands by Infuse. In his letter to Mr. Franken, Mr. King provided details into the study’s numbers. “Only 122 events, or less than 12 percent 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,” wrote Mr. King.
In her statement to the Tribune, Sen. Klobuchar said, “Medtronic and the FDA have both admitted to making mistakes in this case…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.”
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