Medtronic Lawsuit

The Medtronic recall of their Sprint Fidelis leads has sparked an investigation by Congress into the processes the FDA uses to approve implantable medical devices. It is being undertaken by the House of Representatives Oversight and Government Reform Committee.

Last month, Medtronic recalled their defibrillators feature Sprint Fidelis leads after they determined the leads had broken and lead to death in 5 patients. The company had apparently known about the problem of breaking leads for months and done nothing about it prior to October.

Congress feels the inquiry is necessary once it was reviewed that the FDA does not require extensive testing of the vital defibrillator component before goes on the market.  The FDA had required that Medtronic test extensively a previous edition of their leads but not on this one as it was just an improvement of a prior product and not a brand new product. The FDA’s tests only required that the leads undergo stress tests that imitate pressures that are similar to those the body would place on the leads. These tests mainly are there to catch design flaws. The FDA is confused as to why the stress tests did not catch the problem of breaking leads.

If you or someone you know has been implanted with a Medtronic defibrillator, contact the Medtronic Lawyers of Williams Kherkher at 1-866-950-9000 to set up a consultation.