A recent study into the operation of St. Jude’s Riata and Riata ST lead wires indicates that they may be responsible for at least 22 deaths. The defective devices could jeopardize the health and well being of the more than 125,000 people who currently have the implants. The company has challenged the results of the study and has launched its own study to analyze the potential impact on defibrillator patients. Neither St. Jude’s nor the U.S. Food and Drug Administration consider removal of the devices to be in the best interests of patients, as the process of removing them increases the odds of suffering a potentially fatal malfunction.
This is not the first time that the pacemaker industry has dealt with malfunctioning leads. The thin wires that connect the pacemaker to the heart were also the source of problems for Medtronic which estimated that 13 or more people died when their leads failed. Those failures resulted in a $268 million settlement paid to the recipients of the defective leads. St. Jude is currently working to determine how many of their leads have malfunctioned and whether patients face an ongoing threat of an electrical abnormality leading to heart failure.
Both the initial study and St. Jude’s study are seeking a way to test for the deadly defects, before they occur. Given the danger of removing the leads, few are likely to choose that option if the chances of failure are miniscule. For now, the author of the study and St. Jude’s cannot even agree on what is causing the leads to break down. St. Jude’s contends that coating of the wires can break down, causing them to fail. That was the reason St. Jude stopped selling the leads in 2010. The study pointed to a short circuiting problem unrelated to the wire coating.
For the patients affected, the wait to determine if their pacemakers could fail at any moment is interminable. St. Jude has a responsibility to determine whether its device has placed people’s lives in danger and to take steps to correct the action if possible.
Source: USA Today, “Study links St. Jude heart wires to 20-plus deaths,” 28 March 2012