Parker Waichman Alonso LLP, Along With Smith & Nevares, Salas
& Co. 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 Used With a Medtronic Implantable Defibrillator
— MDT
Class Action Status Requested to Benefit All Persons Who
Reside in the United States and Were Implanted With Leads
Manufactured by Medtronic, Inc.
NEW YORK, Oct. 16, 2007 LAWFUEL – The Legal Newswire — Parker Waichman Alonso LLP,
along with Smith & Nevares, Salas & Co. and Becnel Law Firm, LLC,
announce that they have filed a lawsuit on behalf of a man who had to
have a Sprint Fidelis lead emergently replaced as a result of a
fracture. The fracture of the Sprint Fidelis lead required that the man
undergo a surgical procedure known to have the potential for serious
and life-threatening complications. The victim is bringing this action
on his own behalf and as a representative of a class consisting of all
persons who reside in the United States and were implanted with a lead
manufactured by Medtronic, Inc. (NYSE:MDT), except those individuals
whose Medtronic leads have malfunctioned. The suit was filed on behalf
of the victim in the United States District Court for the District of
Puerto Rico (Docket number: 07-1971).
If you or a loved one believes that you were injured as a result of a
Sprint Fidelis lead used with a Medtronic Implantable Defibrillator,
please contact our office by visiting www.yourlawyer.com. Free case
evaluations are also available by calling 1-800-LAW-INFO
(1-800-529-4636).
According to the lawsuit, the victim, a resident of Kentucky, received
a cardiac pacemaker/defibrillator combination (an “ICD”). The ICD was
attached to his heart with a Sprint Fidelis lead wire system
manufactured by Medtronic on March 25, 2005. On June 22, 2006, the lead
had to be surgically removed in an emergency procedure after it was
found to be “frayed” in the nature of a fracture.
The Sprint Fidelis lead is a wire that is used to attach a Medtronic
implantable defibrillator to the heart. Most Medtronic defibrillators
implanted since 2004 use the Sprint Fidelis lead. 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 machines that use the
Sprint Fidelis lead.
Since the Sprint Fidelis lead was introduced to the market in 2004 it
has become evident that a significant portion of the leads have
potentially fatal defects. Such defects were discussed in an article
written by doctors at The Minneapolis Heart Institute, one of the
premier heart institutes in the world, based on a study of the
incidence of lead failures in the Sprint Fidelis models compared to the
Sprint Quattro models. Researchers at The Minneapolis Heart Institute
found that, between September 2004 and February 2007, 583 patients were
implanted with Sprint Fidelis Model 6949 leads and nine patients
received other Sprint Fidelis models. During that time, six patients
experienced Sprint Fidelis Model 6949 lead failures. The failed Sprint
Fidelis Model 6949 leads had been implanted by various
electrophysiologists, cardiologists and thoracic surgeons. The average
time to failure was fourteen months (based on a range of four to
twenty-three months). Medtronic first notified physicians in March 2007
about the high fracture rate of the Sprint Fidelis lead.
In October 2007, Medtronic suspended sales of the Sprint Fidelis lead
used in its implantable defibrillators after an analysis of the
company’s data showed that the lead had 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. According to Medtronic’s
own estimate, approximately 2.3%, or 4,000 to 5,000 people with a
Sprint Fidelis lead will experience fracture within 30 months of having
a defibrillator implanted. Those patients whose Sprint Fidelis lead
fractures must undergo a dangerous surgical procedure to have the wire
replaced.
About Parker Waichman Alonso LLP:
Parker Waichman Alonso 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 Alonso LLP has
assisted thousands of clients in receiving fair compensation for
injuries resulting from defective products, medications and medical
devices.
For more information on Parker Waichman Alonso LLP, please visit:
www.yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).
More information on this and other class actions can be found on the
Class Action Newsline at www.primenewswire.com/ca.
