St. Jude Struggles to Fix Defective Medical Device Problems

St. Jude Struggles to Fix Defective Medical Device ProblemsSt. Jude Medical Inc.'s defective medical device issues may be far from over, data from the company's latest quarterly report indicates.

According to The Wall Street Journal, the rate of failure for the company's Riata-series wires that connect its defibrillator to the heart, called "leads," has increased 17 percent since November. After last year's final quarterly report, the company gave out an advisory, which regulators in the U.S. deemed a recall, that stated the wires could potentially lose their protective coatings, which would pose a danger to blood vessels near the heart.

While reported problems linked to the issue have been few and far between, doctors who have reviewed the defect say that St. Jude's latest report undercounts incidents. Each reported incident is taken from complaints filed by doctors and those products that are sent back to the company for inspection. The reports give no indication of the number of problems that are sent directly to the company. St. Jude ceased sales of the medical device in 2010.

"It still is at a fairly low level, but that doesn't mean we like it," said Bruce Wilkoff, an electrophysiologist at the Cleveland Clinic and a member of St. Jude's independent medical advisory board. "It is by its very nature an underestimate of the issue."

Third-party experts have put the device's failure rate as high as 33 percent, and though the studies are smaller in scope, they still present a variation in failure rates that highlights problems within the industry to track down and report potentially dangerous defective devices, according to the media outlet.

The heart wires' problems were first noted in 2010, leading the company to stop selling the product by the end of that year. St. Jude continued to find problems in 2011, which prompted the first recall, and studies completed in early 2012 have reignited the intense scrutiny.

"It's like we're living in a different universe," said Robert G. Hauser, a Minnesota cardiologist, referring to the highly contradictory information presented by St. Jude and outside researchers.

According to Bloomberg, St. Jude cut all sales of two different forms of the wire in April 2012. While the company said it had not received any reports of injury, it stated that the devices could malfunction, and may fail to deliver potentially life-saving shocks to the heart.