Medtronic Heart Devices May Fail Faster Than Previously Known, New Study Finds
Medtronic Sprint Fidelis heart defibrillator leads, the controversial medical devices recalled in 2007 after being linked to at least five patient deaths and scores of injuries, may be failing to work faster than researchers previously believed, according to a new report.
More than 268,000 of the tiny wires which connect an implanted defibrillator to a patient’s heart were implanted in heart patients to deliver electrical shocks when necessary to correct irregular heart rhythms and prevent fatal heart attacks.
The thin metal wires showed a tendency to fracture and malfunction, causing some defibrillators to deliver unnecessary electrical shocks to patients’ hearts or fail to fire when needed. The defective Medtronic Sprint Fidelis heart defibrillator leads were ordered recalled in October 2007.
Study Finds Increased Fracture Risk
A new study published in the medical journal Heart Rhythm found that Medtronic leads are failing faster than previously known and that the rate of failure seems to be increasing with time. The study was conducted by prominent cardiologists from the Minneapolis Heart Institute and the Mayo Clinic.
The study examined more than 3,000 heart defibrillator patients treated at the two hospitals between 2004 and 2008. About 28 percent of those patients were implanted with Medtronic’s Sprint Fidelis defibrillator leads.
Researchers found that the Sprint Fidelis leads failed at a rate of 3.75 percent, compared to just 0.6 percent for other brands of defibrillator leads. The Sprint Fidelis leads were still functioning in only 88 percent of the patients when examined three years after being implanted, according to the study.
Medtronic Failure Stats Differ
Failure statistics compiled by Medtronic over the same three-year period found that the leads continued to work in about 95 percent of patients. The company said it believes its figures are accurate and that the 95-percent success rate is representative of Fidelis’ overall performance.
Some medical experts have said the researchers may have reached a higher failure rate because they might have relied on reading patient symptoms and counted as failed Medtronic leads that had not actually failed.
What to Do About Failed Leads?
There are serious questions about how best to deal with implanted Medtronic Sprint Fidelis defibrillator leads implanted in patients. Surgery to remove malfunctioning leads is tricky and has lead to deadly complications in some patients. Most surgeons agree that leads which are still working properly should not be removed, since the risks of surgery generally outweigh the risk of the lead malfunctioning.
However, authors of the new study said that in some cases, surgery to remove the leads may be suitable for patients where the risk of surgery outweighs the risk of leaving possibly defective leads in place.
Medtronic Lawsuits Reach Legal Milestones
Hundreds of personal-injury lawsuits filed on behalf of Medtronic Sprint Fidelis victims have resulted in landmark legal rulings. In January 2009, a federal judge in Minneapolis threw all the lawsuits out of court, citing a 2008 U.S. Supreme Court ruling which found that Medtronic and other medical device makers were immune from such suits. That ruling found that federal laws on the topic preempted, or prevailed over, conflicting state rules.
The decision sent shockwaves through the personal injury community and has prompted Congressional and Senate leaders to draft legislation designed to effectively overturn that court ruling. The pending legislation may be introduced soon.
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