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Medtronic Sprint Fidelis Leads
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Medtronic Sprint Fidelis Leads: True Stories and Interviews
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Sprint Fidelis Case Highlights Industry and FDA Failures
 In an article in the March 6 edition of the New England Journal of Medicine, Dr. William H. Maisel says that a flawed medical device approval process at the federal Food and Drug Administration (FDA) and deliberate foot dragging by Medtronic Inc. made the Sprint Fidelis lead debacle far worse than necessary. [ MORE: MEDTRONIC SPRINT FIDELIS INDUSTRY AND FDA FAILURES]
Medtronic Sprint Fidelis: “It might have killed me.”
 Maureen Billings describes herself as "a young 74—I'm very active. I still work, although I'm retired. I do in-store demos—food, mops, wrinkle stuff. And I really enjoy it. I get to know a lot of people and a lot of products that I never thought existed. It's fun." Her enjoyment of life was interrupted—almost permanently—recently when the defective Medtronic Sprint Fidelis leads on her implantable cardiac defribrillator (ICD) failed. [ MORE: MEDTRONIC COULD HAVE KILLED ME]
Medtronic Sprint Fidelis: Texas Man Says Failed Leads Caused PTSD
Larry McCall, a resident of this southeast Texas town, had an implantable cardiac defibrillator (ICD) in his chest. It was intended to monitor his heart condition, and if necessary, deliver an electric shock to his heart that would restore its normal rhythm. Problem is, that ICD was made by Medtronic and used its Sprint Fidelis leads. Those thinner-that-usual leads sat in his heart, and in 2006 they fractured. [ MORE: MEDTRONIC MAY HAVE CAUSED PTSD]
Medtronic: “Proceed with Extreme Caution”
 When Sarah was diagnosed with occipital neuralgia after a car accident, she was told that a Medtronic device would help take her pain away. However, Sarah did not know that the leads in her device would break, causing her to be shocked constantly, and she also did not know that she would have continuous problems with the battery in her device. [ MORE: BE CAUTIOUS WITH MEDTRONIC]
Sprint Fidelis Leads: Medtronic should be Honest
Jane Adams has been dealing with Medtronic since 1999. Prior to having her defibrillator implanted, she trusted the medical device company. However, since a defibrillator with Sprint Fidelis leads was implanted, Adams says she has lost faith in them. [ MORE: MEDTRONIC HONESTY]
Medtronic Leads: "Nothing but Problems"
Patients who have the recalled Sprint Fidelis Leads implanted face a great deal of worry and uncertainty. They do not know whether or not their Medtronic leads will fracture, causing their defibrillator to malfunction. They are told that they cannot have the leads removed because the surgery is too risky; however, they may be able to have the leads capped to prevent any incorrect signals from being sent to the defibrillator. [ MORE: MEDTRONIC - NOTHING BUT PROBLEMS]
Medtronic Sprint Fidelis Should Pay for Surgery
Patients who have the now recalled Medtronic Sprint Fidelis Leads implanted face an important decision. Those who have not suffered from a malfunction must decide whether or not to have the leads capped to avoid having their defibrillator malfunction. [ MORE: MEDTRONIC SURGERY]
Medtronic Sprint Fidelis Leads: Thirty-Two Shocks in Forty Minutes
Thomas Bergstrom is lucky to be alive. On June 28, 2007, his Medtronic defibrillator administered thirty-two shocks to his heart in forty minutes. The reason his defibrillator administered the shocks is that his Medtronic Sprint Fidelis Leads had fractured, sending an improper signal to his defibrillator. Unfortunately for Bergstrom, this was not where his ordeal began. [ MORE: MEDTRONIC SHOCKS]
Medtronic Sprint Fidelis Lead Patients
Medtronic has sent out letters to its patients warning of possible problems with the Sprint Fidelis Leads, recommending that patients have their devices checked to make sure that they are in working order. However, this letter comes too late for some people who are already experiencing serious problems with their Sprint Fidelis Leads. [ MORE: LEADS PATIENTS]
Medtronic Leads Fractured
 "My husband David had a defibrillator installed in August, 2005 but the alarm started going off about a year later," says Sharon H. His doctor thought there was something wrong with the leads so ordered an x ray and discovered that the Medtronic lead had fractured. The Medtronic representative's response? "This never happens." Wrong answer, as many victims of fractured Medtronic leads can attest. [ MORE: LEADS FRACTURED]
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About Medtronic Sprint Fidelis Leads
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Medtronic, Inc. has voluntarily suspended sales of its Sprint Fidelis defibrillation leads --a component of Medtronic's implantable cardioverter defibrillators (ICDs) that link the heart to the ICD. Personal injury lawsuits are now being filed against Medtronic alleging the company is responsible for manufacturing and marketing defective defibrillators.
 Sales stopped after the Sprint Fidelis leads were linked to five patient deaths. The electronic leads can fracture, causing the defibrillator to misread heart rhythms. This can cause the defibrillator to either deliver unnecessary shocks or not deliver shocks when necessary. In addition to the deaths, serious complications have also occurred as a result of lead fracture.
Medtronic estimates that more than two percent of patients fitted with Sprint Fidelis leads will suffer a lead fracture within 30 months of lead implantation. Medtronic will cover the cost of the faulty lead and contribute up to $800 to pay for medical costs not covered by insurance. However, so far the company will not pay for the cost of replacing a lead that has not malfunctioned, meaning that patients who are concerned about a potentially faulty lead will have to pay for the surgery on their own.
There are reportedly around 268,000 leads implanted in patients in the US and around the world. So far, the company and the FDA have only recommended that patients see their doctors to have their ICDs reprogrammed. The reprogramming would better monitor for the potential of lead fracturing. They have not recommended having the leads replaced because such surgery is considered risky, more so even than defibrillator replacement surgery.
Any patients who are not sure if Sprint Fidelis leads were used with their defibrillator should contact a healthcare professional. It is possible that Sprint Fidelis leads were used with defibrillators that were not made by Medtronic.
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Read More About Medtronic Sprint Fidelis Leads
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Supreme Court Decision May Not Shield Medtronic Sprint Fidelis from Legal Action
Make no mistake about it: the recent Supreme Court decision in Riegel v. Medtronic is exactly what the plaintiffs' attorney Allison Zieve calls it: "Pretty bad for patients, pretty good for industry profits." In dismissing a state court lawsuit against Medtronic for the failure of an Evergreen balloon catheter, the Supremes gave Medtronic and other medical device manufacturers a shield against state legal action for any medical device that received pre-market approval (PMA) from the federal Food and Drug Administration (FDA). [ MORE: SUPREME COURT DECISION WITH SPRINT FIDELIS]
Medtronic Sprint Fidelis: A Twisted System
Nearly a quarter million people today are carrying implantable cardiac defibrillators (ICDS) in their chests that use Medtronic Sprint Fidelis leads. If someone's heartbeat suddenly becomes dangerously irregular, these medical devices are supposed to apply a properly calibrated electric shock to restore normal heart function and save a life. [ MORE: MEDTRONIC TWISTED SYSTEM]
Medtronic Sprint Fidelis: Medtronic Tries to Get Off the Legal Hook
If you're a big medical hardware manufacturer and one of your products is found to be seriously—in fact, potentially fatally—defective, what's the right thing to do? That's the challenge that Medtronic Inc. faced when its Sprint Fidelis implantable defibrillator leads were found to be prone to fracturing and malfunctioning, either delivering shocks to patients' hearts at the wrong time or, equally as bad, not delivering shocks at all when they were needed. [ MORE: MEDTRONIC ON LEGAL HOOK]
Medtronic Sprint Fidelis Leads: No Easy Answers
Patients who have had Medtronic Sprint Fidelis Leads implanted are starting to realize that when it comes to what they should do about the leads, there are no easy answers. This is especially true of patients who have not yet experienced defibrillator failure because of fractured leads. Those patients are told that they should not have the leads removed because the surgery is too risky, but they are concerned that at any time their defibrillator could fail, causing them extreme pain and putting their life at risk. [ MORE: MEDTRONIC ANSWERS]
Medtronic Fidelis lead: a Nightmare for Patients
Since Medtronic announced a recall of defective Fidelis leads back in October, pacemaker and defibrillator patients have been handed a dilemma that is nothing short of a nightmare: will the lead fail? Some patients are filing lawsuits against Medtronic, whether or not they have failed. [ MORE: MEDTRONIC PATIENT NIGHTMARES]
Medtronic Sprint Fidelis Leads Investigated
 Medtronic faces two separate investigations involving its [Sprint Fidelis Leads.] The first involves information requested by a Senate panel regarding the Sprint Fidelis Lead recall, while the second investigation, conducted by the US Justice Department, examines allegations that Medtronic made illegal payments to foreign physicians. [ MORE: MEDTRONIC INVESTIGATED]
Potential Malfunction Lawsuits Filed Against Medtronic
Medtronic faces more lawsuits alleging that its Sprint Fidelis Leads caused injury or death to patients using the leads. And lawsuits have been filed by plaintiffs who argue that the potential for a malfunction causes them a great deal of stress and has negatively impacted their lives. [ MORE: MEDTRONIC MALFUNCTION]
Medtronic Recall too Late for Some
Considering that Medtronic knew as early as February about problems with its Sprint Fidelis leads, it seems that October is rather late to be recalling a device that can cause death if it malfunctions. However, according to a report in the Wall Street Journal, despite being told by the Minneapolis Heart Institute about repeated patients experiencing serious problems, Medtronic delayed recalling its Sprint Fidelis Leads for at least seven months. [ MORE: MEDTRONIC RECALL TOO LATE]
Patients Concerned about Medtronic Sprint Fidelis Leads
 Patients who have been implanted with [Medtronic Sprint Fidelis Leads] are understandably concerned after learning that the leads have been linked to five fatalities. Some patients have undergone risky surgeries in order to have the leads removed after they malfunctioned. Meanwhile, lawsuits have been filed on behalf of patients who were injured by fractured leads. [ MORE: LEADS FRACTURED]
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Medtronic Sprint Fidelis Lead Press Releases
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 MAR-10-08: In a blockbuster revelation published in the March 6th, 2008 edition of the New England Journal of Medicine (NEJM), we learn that Medtronic was allowed to take the defective Sprint Fidelis lead to market with only bench testing, without the need for a human trial. [ MORE: SPRINT FIDELIS FAILS ON MARKET AFTER NO HUMAN TESTS]
FEB-20-08: On Wednesday, February 20, the US Supreme Court handed down its decision in the closely watched Riegel v. Medtronic case. Upholding lower court decisions, the Supremes affirmed by 8-1 the dismissal of a state lawsuit brought against Medtronic by the family of the late Charles Riegel. [ MORE: MEDTRONIC LAWSUIT DISMISSED]
NOV-26-07: Medtronic has announced that the massive Sprint Fidelis recall issued in October had an estimated negative sales impact of $130 million and cost the company $31 million in inventory write-offs and other direct costs. [ MORE: MEDTRONIC COSTS]
NOV-15-07: More lawsuits have been filed against Medtronic related to its defective Sprint Fidelis leads. Two Kansas residents have filed class action lawsuits alleging that Medtronic was negligent in the design of its Sprint Fidelis Leads. Both lawsuits also allege that Medtronic failed to warn patients about the possible defects in a timely manner. [ MORE: MEDTRONIC CLASS ACTIONS]
NOV-12-07: Another lawsuit has been filed against Medtronic alleging that its Sprint Fidelis leads malfunctioned causing injury to the patient. Other lawsuits have been filed already, and as time passes and more leads fail, more lawsuits are expected. Meanwhile, patients are upset that a device that was supposed to save their lives is causing so much pain. [ MORE: ANOTHER LAWSUIT]
 OCT-16-07: Barely hours after Medtronic recalled Sprint Fidelis leads associated with its line of implantable defibrillators, the first personal injury lawsuits began rolling out, including one filed in federal court in Minneapolis, where Medtronic is based. [ MORE: MEDTRONIC LAWSUIT]
 OCT-15-07: Medtronic is also urging doctors to stop using the Fidelis lead after hundreds of incidence reports pointing to potential malfunctions. The product is suspected in contributing to five deaths. [ MORE: FAULTY LEADS LINKED TO DEATHS]
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Medtronic Sprint Fidelis In the News:
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JAN-23-08: A Texas man has filed a product liability suit against Medtronic. The man is implanted with an ICD that has a recalled Sprint Fidelis Lead wire system. His complaint alleges "great physical, emotional, and psychological suffering." [ RECORD: MEDTRONIC SPRINT FIDELIS]
JAN-02-08: Patients who have Medtronic devices implanted are left wondering if their devices might actually harm them instead of helping them. [ SENTINEL: MEDTRONIC SPRINT FIDELIS]
DEC-27-07: A man who had Medtronic leads implanted received six shocks in a very short time. Each shock sent 800 volts of electricity into his heart muscle. [ TYLER PAPER: MEDTRONIC SPRINT FIDELIS]
DEC-13-07: One patient has decided to have his Medtronic defibrillator and Sprint Fidelis leads removed after the recent recall. The surgery took 90 minutes and came with a number of risks. [ TIMES: MEDTRONIC SPRINT FIDELIS]
DEC-05-07: Medtronic has announced it is under federal investigation for alleged payments made to doctors. The Senate Finance Committee has request information about Medtronic's suspended distribution of its Sprint Fidelis Leads. [ WALL STREET JOURNAL: MEDTRONIC SPRINT FIDELIS]
NOV-27-07: A woman who is worried about her Medtronic Sprint Fidelis leads malfunctioning has filed a lawsuit against Medtronic. The suit alleges emotional distress and negligence and seeks restitution and medical monitoring. [ KFYR: MEDTRONIC SPRINT FIDELIS]
NOV-12-07: Two Kansas men have filed class-action lawsuits against Medtronic regarding defective SprintFidelis leads that connect the devices to patients hearts. KANSAS CITY: MEDTRONIC LEADS
NOV-5-07: Beth Israel Deaconess Medical Center will host a conference in December 2007 to discuss and examine the safety and reliability of ICD Lead Wires. [ MEDICAL NEWS TODAY: MEDTRONIC SPRINT FIDELIS]
OCT-30-07: The events leading up to the Medtronic Spint Fidelis lead recall expose issues in the U.S.'s medical safety system. It has been revealed that hospitals quit using the devices as early as January of this year. [ WALL STREET JOURNAL: MEDTRONIC LEAD]
OCT-23-07: The Canadian Heart Rhythm Society issued a statement today regarding Medtronic Sprint Fidelis ICD leads. The specialists are working "to seek clarification regarding the nature of the concern, the risks posed to our patients, and potential solutions." [ NEWSWIRE: MEDTRONIC SPRINT FIDELIS]
OCT-19-07: Two Toronto law firms have filed a class action lawsuit against Medtronic and its Canadian subsidiary regarding Sprint Fidelis leads on implantable defibrillators which have been linked to five deaths. [ CTV: MEDTRONIC SPRINT FIDELIS]
OCT-16-07: Two former users of the Sprint Fidelis cardiac leads are suing Medtronic. Both men claim that the defective leads caused them personal injury when their defibrillators would malfunction and jolt them unexpectedly. [ CNN: MEDTRONIC SPRINT FIDELIS]
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Medtronic Sprint Fidelis Legal Help
If you or a loved one has suffered damages in this case, please click the link below to send your complaint to a lawyer to evaluate your claim at no cost or obligation.
Posted on Oct-16-07
Updated on Mar-17-08
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