In St. Jude’s most recent company performance report, its Riata-series “leads” continues to be a major problem.
The failure rate for the leads—wires that connect the defibrillators to the heart—increased by 17 percent since St. Jude’s last performance report in November 2011, according to the Wall Street Journal.
The report only accounts for 0.74 percent of the 79,000 Riatas in use since the end of December 2011. The reports are based on medical devices that are returned for inspection after a patient has the product removed or dies, and on complaints filed by doctors.
After the report, the company issued a medical device recall for the product over concerns that the silicone insulation covering the leads were “at risk of premature abrasion” that could expose conductors inside the leads and cause an “electrical dysfunction,” according to the U.S. Food and Drug Administration.
If you or a loved one has been harmed by an unsafe medical device, contact Sokolove Law for a free legal consultation and to find out if a product liability lawyer may be able to help you. Call us today at (800)-561-7154.