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In March 2009, Medtronic disclosed that at least 13 Sprint Fidelis patients may have died, including four patients whose deaths were related to efforts by doctors to surgically remove the product. In February 2010, the Wall Street Journal reported that the FDA database includes at least 12 additional deaths allegedly linked to the recalled device.
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As noted in our Medtronic heart lead recall blog, the New York Times has issued a story that the U.S. FDA “has revealed that four New Jersey congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees,” an approval it is now revisiting.






