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Another Medtronic Sprint Fidelis Lead Lawsuit is Filed in Federal District Court

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Parker Waichman LLP, along with Smith & Nevares, and Becnel Law Firm, LLC, File Suit against Medtronic Inc., Medtronic Puerto Rico, Inc., and Medtronic Puerto Rico Operations Co. on Behalf of Man Injured by Defective Sprint Fidelis Lead Implanted with a Medtronic Implantable Defibrillator.

(New York) November 2, 2007 – Parker Waichman LLP, along with Smith & Nevares, and Becnel Law Firm, LLC, announce that they have filed a lawsuit on behalf of a man who had to undergo surgery to have a recalled Medtronic Sprint Fidelis Lead replaced after it malfunctioned. The suit was filed on behalf of the victim in the United States District Court for the District of Puerto Rico and has been assigned to Judge Jay A Garcia-Gregory (Docket number: 07-2050).

According to the lawsuit, the victim, a resident of North Carolina, received a cardiac pacemaker/defibrillator combination (an “ICD”). The ICD was attached to his heart with a Sprint Fidelis Lead wire system implanted on January 26, 2006. The defective Medtronic Sprint Fidelis Lead was replaced on April 13, 2007. The victim claims he has suffered and will continue to suffer severe physical injuries, severe emotional distress, and economic losses as a result of the defective Medtronic Sprint Fidelis Lead.

The defective Medtronic Sprint Fidelis Defibrillator Leads were implanted into hundreds of thousands of people, leaving all of them at risk for serious injury and death if the Sprint Fidelis Lead fractures. Medtronic suspended sales and recalled all unused Sprint Fidelis Leads on October 15, 2007 after receiving reports of at least 5 fatalities linked to lead fractures.

The Sprint Fidelis Lead is a wire that is used to attach a Medtronic implantable defibrillator to the heart. The Sprint Fidelis Lead was first introduced by Medtronic in 2004, and has been used with most of the company’s implantable defibrillators since then. This component is used in cardiac defibrillators — or complex devices with defibrillation capacity — and not in conventional pacemakers. Some patients with congestive heart failure use devices that include this defibrillation ability, and those are among the devices that use the Sprint Fidelis Lead.

Medtronic’s Sprint Fidelis Leads have been shown to have a continuing fracture problem. This defect can cause the defibrillators to deliver a massive and painful electrical shock, or it can cause the device to fail to administer a lifesaving shock when necessary. These defects were highlighted in an article written by doctors at The Minneapolis Heart Institute, one of the premier cardiac institutions in the world. The researchers at the Minneapolis Heart Institute compared data regarding lead failures in both the Sprint Fidelis models and Medtronic’s earlier Sprint Quattro models. The study concluded that the thinner Sprint Fidelis Lead had a higher chance of fracturing than the Sprint Quattro. According to Medtronic’s own estimate, approximately 2.3%, or 4,000 to 5,000 people with a Sprint Fidelis Lead will experience a lead fracture within 30 months of implantation.

When a Sprint Fidelis Lead fractures, a patient must undergo a surgical procedure that can tear and scar the heart tissue and veins through which the Sprint Fidelis Lead wire runs. The surgery to replace a defibrillator lead wire is far riskier than having the device which it is attached to replaced.

If you or a loved one received a Sprint Fidelis Lead as part of your implantable defibrillator, please contact the Parker Waichman LLP claims center by visiting www.medtronicdefectlawsuit.com or by calling 1-800-LAW-INFO (1-800-529-4636).

About Parker Waichman LLP:

Parker Waichman LLP is a leading products liability and personal injury law firm that represents plaintiffs nationwide. The firm has offices in New York and New Jersey. Parker Waichman LLP has assisted thousands of clients in receiving fair compensation for injuries resulting from defective products, drugs and medical devices.
For more information on Parker Waichman LLP, please visit: www.yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).

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