In Advance of Safety Meeting, Patients Face Tough Choice

In fact, the issue with the Fidelis leads is the "most widespread problem yet involving a heart device," says the Times. Yet, the financial impact on Medtronic has been less than expected, because it moved so quickly to correct the problem, and because most doctors are recommending that the leads be left in place, with monitoring stepped up.This is why there's a very significant meeting going on today. CDRH officials, doctors, and representatives from device companies are meeting in Boston to discuss how components of heart devices are regulated and consider proposals about how heart devices should be approved and monitored. Expect some important recommendations to eventually emerge.UPDATE: According to a Wall Street Journal blog entry, the session focused on the inadequacy of lab tests to detect lead breakage and the infrequency of doctor reports about it. But there doesn't yet appear to be a consensus about what to do about these things.