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 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.
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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.
(Reporting by Toni Clarke in Washington; Editing by Jonathan Oatis)
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