Quick Facts on the Medtronic Heart Lead Recall

• In January 2007, Medtronic reportedly launched a $100 million marketing campaign promoting the safety of its heart defibrillators, some of which used the faulty leads-event though in 2006 and later in 2007 medical journals reported on early failures of the Sprint Fidelis lead.

• On October 15, 2007, due to reports of at least five patient deaths associated with defibrillator leads sold under the brand name Sprint Fidelis, Medtronic issued a recall of the product. Medtronic stated that the Sprint Fidelis leads were prone to cracking, with potentially life-threatening consequences.

• Your wallet card will specify the manufacturer of your defibrillator leads. The Sprint Fidelis leads that have been recalled have the model numbers 6949, 6948, 6931 and 6930.

• The recalled leads have been implanted in an estimated 235,000 patients since 2004. They are connected to defibrillators either made by Medtronic or by another defibrillator manufacturer such as Guidant or St. Jude for which Medtronic supplied the lead.

• On October 16, 2007, U.S. Senator Charles Grassley called on officials at Medtronic and the Food and Drug Administration (FDA) to explain why "Medtronic took months to stop the sales of the faulty lead, even though the problem had been reported in a peer-reviewed journal months prior."

• On October 19, 2007, the Wall Street Journal reported that the recalled Medtronic heart leads may pose a higher risk of fracture in younger adults and children, a group for whom the devices were often used because of their small diameter. While children are a small share of the patients who received the wires, the leads tend to come under greater stress in more-active people, including kids, adolescents and younger adults.

• On February 20, 2009, the New York Times reported on the February 2008 court ruling that barred patients or their survivors from suing makers of complex medical devices -- like the Medtronic product -- if the Food and Drug Administration has approved their sale. Since that ruling judges nationwide, including the one in St. Paul, have cited it to dismiss cases against a wide range of manufacturers, including Medtronic. But now, some members of Congress want to give potential plaintiffs like Ms. Turnidge a chance for legal recourse. Two House Democrats, Henry A. Waxman of California, the chairman of the House Energy and Commerce Committee, and Frank Pallone Jr. of New Jersey, the head of its health subcommittee, plan to reintroduce soon legislation that would effectively nullify the Supreme Court decision.

• On February 23, 2009, the New York Times reported on a new independent study that concluded that the Sprint Fidelis lead was still functioning in only 88 percent of the patients studied three years after being implanted. By contrast, data collected by Medtronic, using that three-year yardstick, indicated the lead continued to work in about 95 percent of patients. The new study, published February 2009 on the Web site of Heart Rhythm, a medical journal, is based on combined data from 3,000 patients from two major hospitals, the Minneapolis Heart Institute and the Mayo Clinic.

• On March 14, 2009, the New York Times reported that at least 13 people might have died in connection with the Sprint Fidelis heart device that it recalled in 2007 but was still in widespread use, including four patients whose deaths were related to efforts by doctors to surgically remove the product. The new data reflect the first fatality update by Medtronic since October 2007, when it recalled the device — a thin electrical cable that connects an implanted defibrillator to a patient's heart. The company cited five deaths when it recalled the product, saying fractures in the cable could cause a defibrillator to fail to deliver a lifesaving shock to an erratically beating heart, or to fire for no reason.

Contact A Medtronic Recall Personal Injury Attorney | Lawyer

If you or a loved one have been injured by a defective Medtronic heart device, please click here to contact an experienced personal injury attorney at the national law firm of Lieff Cabraser or call us toll-free at 1-800-948-2181. Our personal injury attorneys and legal nurse consultants will promptly review your case for no charge or obligation on your part.

Lieff Cabraser has successfully represented hundreds of patients across America who received faulty or recalled medical devices, including patients with recalled heart devices and pacemakers. Learn more about the unique advantages we offer clients in personal injury or wrongful death cases.