The national product law defect firm Nadrich & Cohen is investigating St. Jude Riata defibrillator leads. We are investigating specifically the wires inside the leads which are the cable that connects the heart to the implantable defibrillator. Unfortunately, many of these leads are breaking through their insulation from the inside out.
What happens is that there is a breach in the insulation and the wires protrude thru the insulation cover.
The product was recalled in 2011. The side effect is the breaking of the wire which can cause the defibrillator to send unnecessary jolts to the heart or fail to deliver the necessary shock to the heart when required.
This side effect is called “inside-out abrasion” and some cardiac doctors had known of the problem from as far back as 2006. The FDA has reported that St. Jude had informed them that they have been tracking problems with the leads for many years. A Wall Street Journal article reflects that the inside-out abrasion problem had been reported since 2005.
Since July 2008, the leads were implanted in more than 13,000 patients. The first warning came in 2010 after doctors publicized reports involving inside-out abrasion occurrences.
Since 2008 the FDA has required post-market studies of defibrillator leads by all manufacturers.
As of July 10, 2012, St. Jude published a study concluding of 19% that all Riata implanted leads have exhibited some signs of inside-out abrasion.
Patients now have to deal with the difficult issue of whether to have the leads surgically replaced. Many patients are having them replaced but many are scared that the lead will not work when needed.
If you or a loved one suffered a serious heart attack or cardiovascular event due to the failure of the Riata lead please contact one our intake specialists at Nadrich & Cohen. You may also fill out the confidential free intake inquiry on the right. We will respond to you within 12 hours.
Since we are contingency lawyers there is no cost or charge to you unless we first obtain a recovery.