Senators press Medtronic for device info (Star Tribune)
WASHINGTON - Three U.S. senators have asked Fridley-based Medtronic Inc. to supply detailed information about how the company keeps track of its medical devices after they go to market.
In a six-page letter that strikes an investigational tone, Sens. Charles Grassley, R-Iowa, Herb Kohl, D-Wis., and Richard Blumenthal, D-Conn., on Thursday called for specific explanations of how Medtronic monitors products once they are released to the public. The letter also seeks specific data about Medtronic's embattled spine product Infuse.
The letter to Medtronic was one of five individual letters sent to different medical device producers whose equipment has malfunctioned after being placed on the market. Grassley, Kohl and Blumenthal also have introduced legislation to require device makers to do clinical studies after their products are offered for sale to the public if those products are approved under a streamlined process that lets them avoid extensive pre-market testing.
Medtronic had no specific comments on the letter's content or contentions. "We have received the letter and are working to comply with their reque...
