The results of a 2004-2008 study by Dr. Robert G. Hauser, Minneapolis Heart Institute, and Dr. David L. Hayes of the Mayo Clinic indicate that the failure rate of Medtronic’s Sprint Fidelis lead is, over time, increasing.
The study involved of 3,000 heart defibrillator leads, 848 of which were Medtronic’s Sprint Fidelis. In comparison to the others, the Sprint Fidelis had a significantly higher rate of failure and was less stable. See: Study Suggests Higher Failures for Heart Device - NYTimes.com
Recently, after citing the Riegel v Medtronic Supreme Court decision, a federal judge threw out hundreds of lawsuits regarding Medtronic’s Sprint Fidelis lead. Please read the NYT link and come back and tell us what you think. Should devices with such a poor track record be protected under FDA preemption?