Posted on February 2, 2016
St. Jude Medical sent a letter to doctors in November advising that several hundred of its Optisure dual-coil defibrillator leads may not work because of damaged insulation on the leads. The insulation on the leads may have been damaged during the manufacturing process. The Optisure lead recall was then announced by the FDA and classified as a Class 1 Advisory. A Class 1 recall means the FDA believes using one of the devices could result in serious health consequences.
Optisure leads are used with implantable cardioverter defibrillators (ICDs). ICDs are used to treat heart rhythm disorders like ventricular arrhythmias, tachycardia and fibrillation. The ICD keeps track of the patient’s heart rate, and the leads deliver an electrical current from the ICD to the heart to restore normal heart rate if the heart rate is erratic or too fast.
The damaged insulation on the Optisure leads may cause the defibrillator not to work: “Depending on device programming and the depth of the inadvertent cut to the insulation, compromise of lead insulation can potentially lead to an electrical malfunction wherein the defibrillator cannot deliver appropriate high voltage therapy.”
A total of 447 St. Jude Optisure Dual Coil Defibrillation leads are recalled worldwide. Of those, 278 were distributed in the United States. The model numbers associated with the recall are LDA220, LDA220Q, LDA230Q, and LDP220Q.
The recall of the Optisure defibrillator leads is not related to St. Jude’s recall of its Riata and Riata II leads in 2011 for premature erosion of the insulation on the wires. That recall lead to approximately 950 personal injury lawsuits against St. Jude which were settled for a total of $14.25 million last year. St. Jude also paid its shareholders $50 million to resolve claims that it provided false information in its 2009 annual report by failing to reveal its knowledge of problems with the Riata leads.
Thornton Law Firm has successfully represented plaintiffs in claims against drug and medical device manufacturers for serious injuries caused by defective and dangerous products. For a free, confidential consultation, you can tell us your story using our online contact form or call Attorney Marilyn McGoldrick at 888-341-1405 for a no-obligation evaluation of your legal case. Time limits for filing claims are short, so seek legal advice as soon as possible.