Defective Lead Wires in Implantable Defibrillators have been Linked to Five Deaths and Hundreds of Injuries
In October 2007, the medical technology company Medtronic voluntarily suspended distribution of its Sprint Fidelis leads. The thin lead wires are a vital part of implantable defibrillators, a lifesaving device that helps regulate patients’ heart rhythms. But a defect in the leads has been linked to at least five deaths and hundreds of injuries.
Even worse, the manufacturer apparently knew about the problem for months before it stopped selling the defective product.
If you are one of the 268,000 patients who may have defective Sprint Fidelis leads, contact your doctor immediately to discuss your medical options.
The MEDLaw Legal Team of Janet, Jenner & Suggs is representing patients and families who have been harmed by the malfunctioning Sprint Fidelis leads. We encourage you to contact our lawyers today for an immediate free claim evaluation. Call 1-888-4-MEDLAW or complete our online claim evaluation form.
The Fidelis lead is a thin wire that runs from the defibrillator to the heart. It allows the defibrillator to monitor the patient’s heartbeat and deliver a lifesaving electrical shock if necessary.
If a fracture or break occurs in the lead, the signal is interrupted. The fractured lead can cause the defibrillator device to release an unneeded and painful shock. The fracture can also drain the defibrillator’s battery and keep it from delivering a shock during a cardiac event. That means at the very moment when the patient’s life depends on the reliability of the leads, the device may malfunction.
The Fidelis leads were introduced into the marketplace in September 2004. By early 2007, about 90 percent of new Medtronic defibrillators used Fidelis leads. However, by January of that year, Medtronic had received 679 reports of injuries caused by fractures in the Fidelis leads.
Medtronic initially attributed the failures to surgical error or variables during the implant procedure, but it soon became apparent that the problem was with the product itself. By June 30, 2007, the number of lead failures resulting in an injury had grown to 1,053. That prompted the company to halt distribution of the product in October 2007.
The Sprint Fidelis lead has been implanted in an estimated 268,000 patients. The lead was used for other defibrillators besides the Medtronic brand, including defibrillators made by Guidant and St. Jude.
Based on information regarding the 268,000 implanted Sprint Fidelis leads, Medtronic said it had identified five patient deaths in which a lead fracture may have been a possible or likely contributing factor. By the company’s own estimates, 2.3% of the patients with Sprint Fidelis leads -- or about 4,000 to 5,000 patients -- will likely experience fractures in the leads.
The Food and Drug Administration has urged anyone with a Sprint Fidelis lead to visit their doctor immediately, especially if they experience palpitations, multiple shocks, fainting or lightheadedness.
Medtronic stated that that the risk of complications was higher for removing defibrillators with the leads than leaving them in place. The company advised patients to have the defibrillators removed only if the Sprint Fidelis leads fractured.
The company also advised patients with Sprint Fidelis leads to see their doctor and have their defibrillators reprogrammed to better monitor any problems.
The MEDLaw Legal Team of Janet, Jenner & Suggs is a nationally recognized law firm dedicated to representing victims of negligently manufactured medical devices like the Sprint Fidelis leads. Our team of seasoned litigators includes physician / attorneys and nurse / attorneys. As reported in national media such as USA Today, Jet Magazine, the Washington Post, and Dateline NBC,
our lawyers have won substantial legal compensation for patients and victims in nationwide lawsuits.
We encourage you to contact our lawyers today. Call 1-888-4-MEDLAW or complete
our online claim evaluation form.
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GUIDANT DEFIBRILLATOR RECALL NEWS & UPDATES:
Guidant Put Speed Ahead of Heart-Device Quality, Ex-Worker Says
Bloomberg - January 13, 2006
...Guidant Corp. reduced training and emphasized production speed
over quality at its troubled factory making implantable heart
devices in St. Paul, Minnesota, according to a 14-year worker who
trained others there. Management set ``unrealistic'' goals for
production of pacemakers and defibrillators and offered incentives
for meeting them...
Implant Recalls Heighten Anxiety
Pittsburgh Post-Gazette - August 21, 2005
... Guidant knew of risks ... But the scrutiny of Guidant and other
defibrillator makers may be just getting under way. In May, the New
York Times said the Indianapolis corporation sold a defibrillator
model it knew had a small risk of malfunctioning, but didn't issue
warnings about it for three years.
Problems
with heart device raise questions
St. Petersburg Times - August 7, 2005
... A group is debating how soon doctors should be notified when
flaws are reported.
Guidant
And FDA Could Face Senate Scrutiny
WCCO.COM - July 31, 2005
... Sen. Charles Grassley, R-Iowa, chairman of the Senate Finance
Committee, asked the FDA to provide documents relating to Guidant's
series of recalls.
New
Report of Problems at Guidant
New York Times - July 30, 2005
... A filing, which was first publicly disclosed earlier this month,
shows that a heart patient implanted with a specific type of Guidant
unit "presented to a hospital" around the beginning of
March after suffering cardiac arrest, an often fatal condition that
the device known as a defibrillator is intended to prevent. This
happened two weeks before a college student with a flawed heart
device died in March.
As Many As 69 Pacemaker Models May Have Failed; Two Deaths and
Dozens of Product Failures Led to Recalls
Consumer Reports - July 26, 2005
... On July 22, the Food and Drug Administration classified
Guidant's recall as Class I, the most serious kind. As many as 69
pacemakers may have failed according to Guidant. All the reported
failures occurred in devices that had been implanted in patients for
at least 44 months.
Guidant adds five additional defibrillators
to warning
SunHerald.com - July 24, 2005
... A second safety warning from Guidant Corp., one of the nation's
largest medical device manufacturers, urged doctors to stop using
five defibrillator models because they could malfunction and may
have to be recalled. Indianapolis-based Guidant announced its second
worldwide safety advisory in a week on Friday, after voluntarily
recalling seven defibrillator models last week. The pager-sized
devices sense an irregular heart rhythm and shock the heart back
into correct beating. At least 74,900 defibrillators are now under a
company warning.
The warnings include the Contak Renewal 3 model, the company's
largest seller, and Contak Renewal 4, as well as the Renewal RF. It
also covers the Renewal 3 and the Renewal 4 AVT models.
Guidant's Defibrillator 'Fix' May Raise
Other Risks
Indianapolis Star - July 23, 2005
The
Guidant Corporation said Friday that one of its recent
recommendations for correcting problems with some of its
defibrillators might actually increase the risk of malfunction in
three models implanted in about 21,000 heart patients. The company
said a programming change that it suggested to doctors in June might
"significantly increase" the risk that a magnetic switch in the
Ventak Prizm, Vitality and Contak Renewal devices would become stuck
and prevent them from providing treatment.
UPDATE 2-Guidant revises recommendations on
ICD fix
Reuters - July 22, 2005
... CHICAGO, July 22 - Guidant Corp. on Friday revised its
recommendations about how to handle problems with some of its
recalled implantable heart devices because of increased risk to
patients.
F DA Announces
Guidant’s Class I Pacemaker Recall
U.S. Food & Drug Administration
Website - July 22, 2005
... The U.S. Food and Drug Administration (FDA) is notifying
health care providers and patients that Guidant Corporation is
voluntarily recalling certain pacemakers. A seal within the devices
can leak, allowing moisture to affect the electronic circuits. This
defect can cause the pacemakers to fail to provide pacing or can
cause a rapid heart rate. Other unexpected device behaviors are also
possible. The problems may occur without warning and can lead to
loss of consciousness, and possibly heart failure and death.
FDA Gives Highest Warning About Certain Guidant Defibrillators
The government says a malfunction in some of the
Guidant Corporation defibrillators recalled recently could cause
serious injury or death. ...
Guidant defibrillators recalled
A series of failures in Guidant Corp. defibrillators
that resulted in two deaths prompted the company to issue warnings
to doctors ...
FDA halts expansion of network to monitor medical device safety
North Reading medical technology consulting firm,
said data from more hospitals might have led to earlier detection of
problems with Guidant's defibrillators. ...
Lawsuit claims faulty implanted defibrillator caused death
The lawsuit, filed Wednesday in Duval Circuit Court,
claims Guidant, of Indianapolis, was aware of problems with its
defibrillators for about three years, but ...
FDA: Some Guidant Defibrillators Recalled
The FDA says Guidant Corp. is recalling certain
implantable defibrillators and cardiac resynchronization
defibrillators. ...
New worry for heart patients as Guidant defibrillators are ...
The latest Guidant safety announcement affects the
Contak Renewal 3 model, Contak ... At least 74,900 defibrillators
worldwide are now under a safety warning, with ...
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