Problems With Riata ST Optim Lead
St. Jude Riata Defibrillator Lead wires have raised concern among both doctors and patients as the leads have been reported to pierce heart wall of the patients. Many cases suggest that these wires detach from patients’ hearts and are puncturing the heart wall. There are many reports published in medical journals that support this fact. Though this type of defibrillator lead malfunction could occur with any lead insulation, it is evident that Riata ST Optim Lead insulator by St. Jude, are showing frequent cases of such malfunction.
The company too has warned doctors about a higher rate of failure associated with Riata. Riata has a 0.63 percent failure rate. St. Jude came to this conclusion based on returns and complaints figures of 9 years. This method is known for underestimating the actual failure rate. The company too agrees to this fact. According to Sanford C. Bernstein & Co. analyst Derrick Sung around 20 out of 25 doctors surveyed have shown concern about failure of Riata ST Optim Lead insulator. Doctors expressed concern over other leads by St. Jude too.
An article published by a medical journal “Pace” too supports the fact. The article gives detail of four instances of Riata Defibrillator Leads getting detached and poking in the heart wall. One such instance shows that St. Jude Riata Defibrillator Lead perforated so deep that it was only 7 millimeters away from the patient’s skin. Dr. Stephen Vlay, a cardiologist for Stony Brook University in New York, attributes problem with Riata ST Optim lead to flaw in design in models, which are malfunctioning.
Another medical journal “Heart Rhythm” also reported about the higher rate of piercing by the St. Jude Riata Defibrillator Lead. The article site reports by doctors at Massachusetts General Hospital, which states a perforation rate of 3.8% – or 5 out of 130 – for the St. Jude Riata Defibrillator Lead insulator. New York Hospital Queens reported about 5 such cases out of 59 implants of St. Jude Riata Defibrillator Leads. It also stopped using Riata leads.
A defibrillator lead is a thin wire, which is used to attach a defibrillator to the heart for the purpose of defibrillator implantation. Defibrillator emits electric shocks, which through the defibrillator lead 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. This bleeding could cause problem 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 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.
St. Jude points to the cases where removal of a Riata lead with externalized conductors had caused death of two patients and one case of serious injury. One death and injury in patients were also reported with externalized conductors, which were not related to the insulation issue.
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.