A reported insulation defect in defibrillators made by St. Jude Medical could lead to potential failure of the device and resultant patient injuries or even death.
A leading cardiologist suggested doctors stop using the defibrillators following his study suggesting that a new material used to coat the lead wires of devices was breaking down prematurely – in devices implanted four years or less -- and leading to failure in some cases.
If you or someone you known suffered serious injury or death as a possible result of a defective defibrillator, you should call us at 800-243-1100 to speak with a defective defibrillator attorney. Kline & Specter, PC, with more than 40 attorneys, five of whom are also doctors, has the expertise to litigate defective defibrillator cases.
The potentially faulty defibrillator leads made by St. Jude are the Riata ST Optim and the newer Durata ICD, the latter of which has been implanted in 276,000 patients.
The study (published Aug. 21, 2012) revealing possible lead insulation defects was conducted by prominent cardiologist Dr. Robert Hauser of Abbott Northwestern Hospital in Minneapolis, who cited a troubling number of problems with the defibrillators reported to the U.S. Food and Drug Administration (FDA). The doctor found 52 such reports for both defibrillator models.
The new insulation, a substance made of silicone and polyurethane, was meant to provide better protection against failures due to abrasion. But, according to Hauser, it has not turned out that way. Instead, leads have sometimes failed due to problems with the insulation.
The leads are used to send electricity to the heart from the defibrillator body, which then delivers a shock to the heart to correct a dangerous cardiac rhythm.
The FDA has recommended that patients with the older leads made by St. Jude, the Riata, undergo imaging testing to try to determine if the device is beginning to fail. It also mandated that the company perform additional studies on both the older and newer leads.
Kline & Specter, PC represents people injured by defective defibrillators nationwide. Please call us at 800-243-1100 for a free claim evaluation.