The Riata and Riata ST defibrillator leads manufactured by St. Jude are being linked with Cardiac Tamponade. Cardiac Tamponade refers to accumulation of fluid in heart sac. Experts on medical devices anticipate lawsuits following the defective and hazardous nature of the device leads.

The defibrillator leads used in Riata devices is a thin wire, which is used to attach a defibrillator to the heart while implanting. Defibrillator emits electric shocks, which through the device travels to the heart and helps to maintain its rhythm. If a defibrillator lead wire detaches, the device stops working and it could prove fatal for the patient. Patient could even die in case of defibrillator failure. Some times these detached wires pokes into heart wall could cause bleeding in the pericardial sac around the heart. This bleeding could cause cardiac tamponade, which is a serious medical condition. In this medical condition pressure builds around the heart and its beating becomes uneven or irregular.

The reports related to malfunctioning of these leads started as early as in November 2007. These reports indicated that St. Jude Riata Defibrillator Lead wires had detached and pierced the heart walls in some patients. The medical journal Pace also published a report siting four instances of St. Jude Riata Defibrillator Lead wire malfunctioning that showed that these lead wires detached and perforated the heart wall.  One such instance suggested that the defective St. Jude Riata Defibrillator Lead wire has poked dangerously deep and was only few millimeters away from the patients skin.

St. Jude Medical the manufacturer of the Riata and Riata ST defibrillator lead wires for implantation in patients for regulation of heart rhythm. The company has stated that that there is a memory chip problem in a small number of some of its older devices. It also issued an advisory letter to physicians advising them to stop using these leads as hey are showing a higher rate of failure. The FDA also hit St. Jude Medical Inc.’s Riata with a Class I recall. These facts are surely going to act against the company in many cardiac tamponade lawsuits in the offing.

The St. Jude Riata Defibrillator Leads causing heart perforations are mostly models with thin diameter. Previously one such thin diameter lead wire the Sprint Fidelis Lead was pulled from the market due to the problem of detachment and piercing in the heart wall. It was manufactured by Medtronic Inc. There are assumptions that the thin design of these lead wires is posing problem of detachment and perforation. The U.S. Food & Drug Administration also investigated the association of defibrillator lead wire diameter with safety and performance issues. It called for a class I recall of Riata and Riata ST Silicone Defibrillation Leads. Class I recall is stringent form of action, which is taken after many cases of death and serious injurious due to any medical product or drug are reported.

The affected model numbers are the Riata (8F) Silicone Endocardial Defibrillation Leads (Models 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, and 1592), and the Riata ST (7Fr) Silicone Endocardial Defibrillation Leads (Models 7000, 7001, 7002, 7010, 7011, 7040, 7041, and 7042). The company has already stopped distribution of Riata and Riata ST leads since last year.

The company might be facing numerous lawsuits and would have to pay compensation as its advisory letter and FDA class I recall favors the fact that these leads were defective.