St. Jude Riata Lead Recipients Warned to Get X-RaysAug 17, 2012 | Parker Waichman LLP
The Food and Drug Administration issued an alert this week to people who rely on an implanted cardiac defibrillator that uses the Riata or Riata ST leads. The agency believes anyone with these recalled leads should have an X-ray or some other type of appropriate medical scan to determine if there are any safety concerns with those known defective wires.
The Riata and Riata ST leads were recalled by St. Jude Medical in November of last year after succumbing to the conclusion that the insulation protecting their conductive ends was inferior and defective. The lead conductive ends were prone to break out of that insulation and cause serious injuries and potentially death to those who experienced the defect.
About 79,000 people in the U.S. still rely on the Riata and Riata ST leads for their ICDs to function properly. They deliver the life-saving shocks to their hearts that keep it beating or in rhythm. When these leads fail as they're prone to do, they can deliver a shock when they're not supposed to or not deliver one when it is supposed to function. The exposed conductive ends can also cause internal lacerations to the heart and the muscle and tissue protecting the heart.
The FDA recently convened a conference to determine how best to treat the tens of thousands of patients who still rely on these recalled defibrillator leads. Recommending their immediate removal from patients is seen as too risk as the surgeries often put patients at greater risk of complications than the actual defective devices.
Instead, the agency believes that regular X-rays will help a physician determine if there is any signs of abnormalities that led to Riata and Riata ST's recall last year. After receiving a scan, a doctor will be able to determine if there has been any change in the conductive end housing's integrity.
“The majority of Riata and Riata ST leads, including those that show signs of electrical conductor migration or externalization, continue to function normally and provide life-saving support for patients,” Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, said in the agency's statement. “However, the agency does not have enough information to determine the frequency and timing of insulation failure in these leads; therefore, the postmarket surveillance studies will ensure that health care professionals and patients get the data they need to better guide clinical management decisions.”
At the same time, the FDA is also requiring St. Jude Medical to conduct a three-year post-market study that should be aimed at determining the early signs a person could be experiencing failures with the Riata and Riata ST leads. It has also ordered the same tests for the company's other ICD leads, the QuickFlex, QuickSite, and Riata ST Optim and Durata leads.