Lawsuit claims that Sprint Fidelis® heart defibrillator resulted in unnecessary shocks, hospitalization of client.
Evansville, Ind. (PRWEB) April 8, 2008 -- Evansville-based law firm Woods and Woods filed a lawsuit against medical device manufacturer Medtronic, Inc., alleging that a defect in the company's Sprint Fidelis® heart defibrillator cardiac lead wire resulted in inappropriate shocks, severe pain, and hospitalization of their client. The suit also claims that Medtronic, which is headquartered in Minneapolis, Minnesota, concealed or downplayed the known health risks to continue marketing and selling the device worldwide (Case No. 3:08-cv-RLY-WGH filed in the U.S. District Court for the Southern District of Indiana, Evansville Division).
According to the suit, Woods and Woods' client received the Medtronic Sprint Fidelis Defibrillator Lead Wire (model no. 6949) Feb. 7, 2005, and on March 28, 2006, the device began to malfunction. Specifically, the lead wire in the device fractured, causing the defibrillator to send unnecessary and painful shocks to her heart.
"Many people have been affected by these devices and may be in danger of experiencing life-threatening side effects," said William Woods, managing partner at Woods and Woods. "We are offering our assistance to anyone who has been harmed by one of these products and are here to help in any way we can."
On Oct. 15, 2007, Medtronic removed its Sprint Fidelis heart defibrillator cardiac leads from the market after reports surfaced that linked the devices to patient deaths. The same day, the Food and Drug Administration (FDA) stated that these electronic wires may be prone to fracture, which can cause the defibrillator to deliver unnecessary shocks or not operate at all. The FDA also said it was aware of some deaths and/or major complications occurring after the leads had fractured.
What Is a Lead Wire?
The Medtronic Sprint Fidelis has an electrical wire that connects implantable cardioverter-defibrillators (ICDs) to the heart. This wire is called a "lead." Defibrillators (ICDs) monitor the rhythm of the heart and will deliver electric shocks directly to the heart if it begins to beat dangerously fast. The cardiac leads in question are placed on the heart's muscles and then attached to a device implanted in the body that is designed to maintain an appropriate heartbeat. These leads, however, may break down and deliver unnecessary, painful, and life-threatening shocks to people who have them implanted in their heart muscles.
How Many People Are Affected?
Medtronic said 235,000 people have these Sprint Fidelis cardiac leads in their bodies. The affected models are in the "Sprint Fidelis" family of Medtronic leads. The affected model numbers are 6930, 6931, 6948, and 6949, and these encompass ALL Sprint Fidelis models. These leads were manufactured between September 2004 and October 2007.
About Woods and Woods
Based in Evansville, Indiana, Woods and Woods is a family-operated law firm dedicated to representing the rights of individuals injured or disabled by the negligent conduct of others. Since its establishment in 1985, Woods and Woods lawyers and staff members have actively participated in the well-being of the community through involvement in youth sports, scouting, and by annually sponsoring the Safe and Sober Free Ride Home program. Visit www.WoodsLawyers.com to learn more.
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