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Sprint Fidelis Articles

Medtronic Sprint Fidelis: Four Have Died During Extractions

Medtronic Sprint Fidelis: Four Have Died During Extractions April 8, 2009. By Gordon Gibb.
Washington, DC Two years after Medtronic stopped selling the vilified Sprint Fidelis lead, there is a growing concern as to its continued viability—and while Medtronic and the medical community in general recommend not replacing working leads unless they fail, some doctors are doing just that.
Read [ Medtronic Sprint Fidelis: Four Have Died During Extractions ]

Failure Rate of Medtronic Sprint Fidelis Lead Could Be Higher

Failure Rate of Medtronic Sprint Fidelis Lead Could Be Higher February 24, 2009. By Gordon Gibb.
Minneapolis, MN Patients with the Medtronic Fidelis Sprint lead, a medical device that connects to the heart and was expected to be effective in 95 percent of patients in spite of a recall two years ago, may be worse off than first thought. A new study suggests that three years after implantation the Sprint Fidelis lead is only expected to remain functional in 88 percent of patients.
Read [ Failure Rate of Medtronic Sprint Fidelis Lead Could Be Higher ]

Medtronic Sprint Fidelis Leads Sparked "Extreme Anxiety"

Medtronic Sprint Fidelis Leads Sparked "Extreme Anxiety" October 17, 2008. By Heidi Turner.
Houston, TX Patients who have been affected by the 2007 Medtronic Sprint Fidelis lead recall are contacting lawyers to determine whether or not they have a claim against Medtronic. While some people have actually been harmed by fractured Sprint Fidelis leads, others say they constantly live with the fear that their defibrillator will not work as promised, a potentially fatal problem.
Read [ Medtronic Sprint Fidelis Leads Sparked "Extreme Anxiety" ]

Medtronic Sprint Fidelis Update: The News is No Better

Medtronic Sprint Fidelis Update: The News is No Better August 26, 2008. By Gordon Gibb.
Minneapolis, MN It's been several months since the Medtronic Sprint Fidelis lead recall made headlines after defibrillator patients experienced inappropriate shocks due to a fracture in the super-thin lead. However, the story is still at play: lawsuits keep coming in, and continued research verifies the problem with the Medtronic Sprint Fidelis.
Read [ Medtronic Sprint Fidelis Update: The News is No Better ]

Sprint Fidelis Case Highlights Industry and FDA Failures

Sprint Fidelis Case Highlights Industry and FDA Failures March 12, 2008. By Paul Halpern.
Waltham, MA 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.
Read [ Sprint Fidelis Case Highlights Industry and FDA Failures ]

Medtronic: It's Not Just Sprint Fidelis

Medtronic: It's Not Just Sprint Fidelis March 11, 2008. By Paul Halpern.
Rancho Mirage, CA Sandy Wells never had an implantable cardiac defibrillator with defective Medtronic Sprint Fidelis leads in her body. That's the good news. The bad news is that she did have a Medtronic Synergy neurostimulator implanted under her arm in hopes of relieving her chronic migraine headaches.
Read [ Medtronic: It's Not Just Sprint Fidelis ]

Medtronic: No Human Testing of the Failed Sprint Fidelis Lead

Medtronic: No Human Testing of the Failed Sprint Fidelis Lead March 10, 2008. By Gordon Gibb.
Stamford, CT 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.
Read [ Medtronic: No Human Testing of the Failed Sprint Fidelis Lead ]

Medtronic Sprint Fidelis: "I'm beginning to wonder if any of their leads are worth a crap."

Medtronic Sprint Fidelis: "I'm beginning to wonder if any of their leads are worth a crap." March 7, 2008. By Paul Halpern.
Wyoming, MI At first, Lisa Kraft's story sounds like a classic Medtronic Sprint Fidelis failure. She had a Medtronic device implanted last fall; early this year, one of the leads failed, and a month later was found to have fractured. Now she's trying to decide what to do: Have the lead replaced? Leave the device in place and hope for the best? Get rid of it altogether?
Read [ Medtronic Sprint Fidelis: "I'm beginning to wonder if any of their leads are worth a crap." ]

Medtronic Sprint Fidelis: "It might have killed me."

Medtronic Sprint Fidelis: "It might have killed me." March 4, 2008. By Paul Halpern.
Loves Park, IL 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.
Read [ Medtronic Sprint Fidelis: "It might have killed me." ]

Supreme Court Decision May Not Shield Medtronic Sprint Fidelis from Legal Action

Supreme Court Decision May Not Shield Medtronic Sprint Fidelis from Legal Action February 24, 2008. By Paul Halpern.
Washington, DC: 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).
Read [ Supreme Court Decision May Not Shield Medtronic Sprint Fidelis from Legal Action ]