St. Jude Riata Defibrillator Lead Wires Perforating Patients' HeartsNov 12, 2007 | Parker Waichman LLP
St. Jude Riata Defibrillator Lead wires have been detaching from patients’ hearts and perforating the heart wall, according to reports published in a major medical journal. While such malfunctions can happen with any defibrillator lead, evidence is emerging that such detachment and perforation is occurring more frequently than expected with the St. Jude Riata Defibrillator Leads.
A defibrillator lead is a thin wire that attaches an implantable defibrillator to the heart. It is through the lead wire that electrical shocks emitted from the defibrillator will travel to the heart. When a defibrillator lead wire detaches, the device will fail, leaving a patient at risk for death. And if the wire perforates the heart wall, the heart can bleed into the pericardial sac around it. This causes a lethal condition called cardiac tamponade in which pressure builds around the heart, preventing it from beating effectively.
An article to be published online today by the medical journal “Pace” details four instances where St. Jude Riata Defibrillator Leads detached and poked holes through the heart wall. In one of those instances, the St. Jude Riata Defibrillator Lead came within just 7 millimeters of poking through a patient’s skin. In an editorial accompanying the “Pace” article, Dr. Stephen Vlay, a cardiologist for Stony Brook University in New York, wrote that the problems with the St. Jude Riata Defibrillator Leads could be due to an “inherent design flaw, at least in some models of the Riata lead.”
Many of the St. Jude Riata Defibrillator Leads that have caused heart perforations are thin diameter models. In October, another thin-diameter lead wire manufactured by Medtronic Inc, the Sprint Fidelis Lead, was pulled from the market because of a fracturing problem. There is some speculation that the thin design of Sprint Fidelis and Riata lead wires are causing the perforation and fracturing problems seen recently. According to the Wall Street Journal, the Food & Drug Administration is currently investigating the link between defibrillator lead wire diameter and such safety and performance issues.
For its part, St. Jude insists that its own monitoring of the Riata Defibrillator Lead indicates that is no more likely to perforate patients’ hearts than other lead wires. According to the company, its data suggests that the St. Jude Riata Defibrillator Lead has only a 0.33% rate of perforation. However, Dr. Vlay told the Wall Street Journal that St. Jude’s data might not be providing a complete picture of Riata lead failures, as many physicians do not bother reporting perforation incidents.
Dr. Vlay could be right, as “Pace” is not the only publication to report perforation problems associated with the St. Jude Riata Defibrillator Lead wires. Earlier this year, the medical journal “Heart Rhythm” reported that the St. Jude Riata Defibrillator Lead had a higher perforation rate than what had been stated by the manufacturer. According to that article, doctors at Massachusetts General Hospital reported a perforation rate of 3.8% - or 5 out of 130 – for the St. Jude Riata Defibrillator Lead. Doctors from New York Hospital Queens also reported to “Heart Rhythm” that of 59 St. Jude Riata Defibrillator Leads implanted there, five had perforated. New York Hospital Queens has since stopped using the defective St. Jude Riata Defibrillator Lead.