The U.S. Food and Drug Administration (FDA) has warned St. Jude Medical to address safety issues concerning the company’s Durata heart device – an electrical lead wire that connects an implanted defibrillator to a patient’s heart. This implantable cardioverter defibrillator (ICD) lead may fail by not sufficiently preventing insulation abrasions that can cause patients to experience debilitating shocks and even die.

St. Jude Looking At Fines & Penalties

According to a recent article in the New York Times, the FDA raised numerous concerns about the company’s Durata ICD lead wire during a company inspection last fall. In a letter dated January 10, 2013, the FDA threatened to fine the medical device manufacturer and penalize it by refusing to approve applications for the company’s other complex medical devices until the Durata issues were addressed.

Although St. Jude has disclosed the FDA’s warning letter to the Securities & Exchange Commission (SEC) and said that it was “giving the highest priority to fully remediating these concerns,” no action has yet been taken.

Study Shows Faulty Defibrillator Leads Responsible For Numerous Injuries & Death

According to a study recently published in the medical journal, Europace,  there have been over 50 reports of injury and several deaths due to St. Jude’s Durata and Riata ST Optim defibrillator lead failures. Both of these devices replaced St. Jude’s recalled Riata-series leads, which the company stopped selling in late 2010 and recalled in 2011. Approximately 350,000 patients have been implanted with the Durata and Riata ST Optim wires.

Defective & Dangerous Medical Devices

Manufacturers who place dangerous or defective medical devices on the market must be held responsible for those products when they cause injury or death. If you’ve been injured by a defective St. Jude defibrillator lead wire or any other medical device, contact The Driscoll Firm, LLC, to discuss your situation and determine if you might be entitled to compensation.