In a letter addressed to St. Jude Medical, Inc., a global medical device manufacturer, the U.S. Food and Drug Administration (FDA) announced a Class I Recall regarding the performance of Riata® and Riata® ST Silicone Defibrillation Leads. Subsequently, the Class I recall was initiated because of the potential risk of serious injury or death if a device should malfunction. However, an estimated 79,000 Riata and Riata ST family of silicone leads remain active in patients in the United States. Furthermore, a recent study has confirmed that the recalled cardiac leads have a higher electrical failure rate compared to other available leads.
Manufactured by St. Jude Medical, Inc., Riata and Riata ST Silicone Defibrillation Leads are specific models of cardiac electrodes (thin wires) that connect an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to localized cardiac tissue. ICDs and CRT-Ds are devices that monitor and regulate a patient’s heart rate by providing pacing and delivery of high voltage therapy for ventricular arrhythmias.
Unfortunately, however, an influx of adverse reports have exposed potentially dangerous and life-threatening complications with these leads. Those with externalized conductors may develop electrical dysfunction and not work as intended. This may cause serious health consequences, including death.
In response to the growing concerns, Edmund Keung, MD, of the University of California San Francisco, conducted a retrospective analysis of the defective leads. Keung and colleagues performed an electrical survival analysis of the Riata/ST, Quattro, Fidelis, and Endotak leads using data collected by the VA National Cardiac Device Surveillance Center. The study included 24,300 patients who had remote transmissions from 2002 to 2012. Leads included 1,403 Riata/ST, 6,091 Quattro, 5,072 Fidelis, and 2,401 Endotak. Overall, there were 466 lead failures documented during the study.
According to his research, the 5-year survival rate for the Riata/ST leads was 97.5%, which was significantly lower than the rates with the Sprint Quattro Secure and Endotak Reliance G/SG leads (99.2% and 99.5%, respectively, P<0.0001). Among the 47 Riata/ST failures, one patient did not have a revision, 17 underwent extraction, and 29 had new leads implanted without removing the old ones.
“Careful long-term follow-up should be maintained in patients with Riata/ST in order to prevent inappropriate shocks or failed device interventions,” said researchers associated with Keung’s study. “Our results … suggest that large-scale remote monitoring may be an effective tool for continued ICD system surveillance.”
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