The Cochran Firm Legal Blog

In 2007, Medtronic recalled their Sprint Fidelis lead, a cable that was part of a defibrillator implanted in heart patients. It connected the person’s heart to the defibrillator and when the heart rhythm faltered it sent an electric shock to restore a proper heartbeat. But this cable was flawed and prone to fracturing. It delivered shocks when none were needed, and in some cases delivered no shock when one was needed.

In February, 2009, two cardiac specialists published a report of a study done on the Medtronic defibrillators that were still being used. Even though the cable was recalled, many heart patients still have these defibrillators implanted, because surgery to remove them brings more risk to them and in some cases has already caused death.

Two Studies: Two Different Results

First Study

The recent study reported was of 3,000 patients from two large hospitals: the Minneapolis Heart Institute and the Mayo Clinic. The two authors are employed at these hospitals, one at each hospital. They found that the Sprint Fidelis lead was correctly functioning in only 88 percent of the patients studied. The patients had been implanted with this defibrillator for three years at the time of study.

Of the 3,000 patient leads included in their study, only 848 were sprint Fidelis leads, which is about 28 percent. When they ran their numbers, the researchers found that the annual failure rate of Sprint Fidelis leads was 3.75 percent, as compared with the failure rate of the other leads, which was 0.6 percent. They also found that the Sprint Fidelis rate was increasing.

Second Study

Medtronic has also done a study of patients who have had the defibrillator implanted for three years. Their results showed that the Sprint Fidelis lead was functioning correctly in 95 percent of cases. Medtronic released a statement saying: “It is important to note that data collected from center to center would be expected to vary. We believe that our analyses are representative of overall Fidelis performance.”

Other physicians have commented on the differing figures arrived at by these two studies and theorized that:

• Perhaps many cardiologists have not reported problems to Medtronic, which leaves the company with deficient data
• Perhaps some cardiologists are interpreting patient symptoms as caused by Sprint Fidelis lead fractures when no fracture had happened
  

Medtronic has reported that they are monitoring about 21,000 patients nationwide and that underreporting by cardiologists is not a problem. The spokesman also pointed to a recent Canadian study which had results very similar to those of Medtronic.

Hundreds of Lawsuits

Since the 2007 recall of the Sprint Fidelis lead there have been hundreds of lawsuits against Medtronic. However in January of 2009, a federal judge dismissed them all because of a Supreme Court ruling in 2008 which decided that federal law shields the manufacturers of some medical devices from defective product lawsuits.

If you have been injured by a malfunctioning medical device and are wondering if you might have a valid legal claim, please contact our defective product attorneys today to set up a free consultation.