< "http://www.yourlawyer.com/practice_areas/defective_drugs">Riata defibrillator cables are being discontinued by St. Jude Medical Inc. following revelations that an insulating material is likelier to cause malfunctions, reported Fox Business.
St. Jude wrote to physicians in a letter Wednesday explaining that cables with newer coating experienced fewer problems and have nearly replaced the older versions on the market, said Saint Jude, according to Fox Business. St. Jude recommends that physicians continue monitoring those patients with the â€œRiataâ€ brand cables while they test for potential lead failures in those patients in which there is a concern, said Fox Business; 227,000 of the faulty cables have been sold worldwide.
Meanwhile, a U.S. Food and Drug Administration (FDA) spokeswoman said that the issue does not yet warrant a recall, said Fox Business. Also, St. Jude said that it does not recommend that the cables be removed, describing the procedure as complex, said Fox Business. The St. Jude medical advisory board agreed.
The problem exists with “Riata and Riata ST” leads, or cables, that connect defibrillators to the heart; silicone is used as the cablesâ€™ exterior insulation, said Fox Business. In its physician letter, St. Jude said that a 0.47% rate of “insulation abrasion” over nine years of use with the defective leads, noting that the phase-out should be completed by year-end, explained Fox Business.
It seems that the defective insulation can intrude on how the cable senses cardiac rhythm problems.
Implantable defibrillators are meant to keep the heart beating regularly and to shock the heart back to its proper rhythm in the event the heart stops. A defibrillator lead is a thin wire attached to the heart wall that delivers an electrical impulse via the defibrillator. When a defibrillator wire detaches or breaks, the device will fail leaving a patient at risk for death because the device does not sense the need for a shock, is unable to deliver the shock, or delivers an unnecessary shock. If the wire perforates the heart wall, the heart can bleed into its pericardial sac causing cardiac tamponade, a lethal condition where pressure builds around the heart preventing it from beating effectively. Unfortunately, heart perforation is generally discovered after the wire has made its way through the heart wall.
In its letter, St. Jude said the newer leads insulation is called â€œOptimâ€ and has exhibited better than an 80 percent reduction in so-called “abrasion-related observations” after 44 months versus leads made with silicone, said Fox Business, which noted that the Optim insulation is comprised of both silicone and polyurethane.
“The insulation is the weakest link” for defibrillator leads, said Haris Haqqani, an electrophysiologist at the Hospital of the University of Pennsylvania, quoted Fox Business.
Weâ€™ve previously written that many patients who have been implanted with heart devices are not aware of recent recalls and do not understand the dangers they might face, pointing to a lack of understanding among doctors and patients about heart disease and the devices used to treat it. Also, recalls of implanted defibrillators have forced some patients to have them removed.