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Resource ID: #27880
Subject: Medical Reporting
Source: Minneapolis Star-Tribune
Affiliation: 
Date: April 10, Oct. 16

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Description

America depends on the timely notification of injuries to protect patients from dangerous medical devices. But as a Star Tribune investigation showed, companies can break injury-reporting laws with impunity. First, the newspaper exposed a long-lost Medtronic study of a controversial bone-surgery product called Infuse. The study documented more than 1,000 serious problems that were not provided to the government during a period of heightened scrutiny of the product's safety. When Medtronic did report the data to the FDA, more than five years late, the FDA secretly granted Medtronic permission to summarize the data in a file that would be available to the public only under a FOIA request. The Star Tribune went on to document hundreds of these “retrospective summary reports” of long-overdue unreported device reports from two dozen companies.

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