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Joseph H. Saunders

Sprint Fidelis Pacemaker Had Problems Last Winter

Medtronic, the manufacturer of the Sprint Fidelis cardiac defibrillator a.k.a. pacemaker, knew that its medical device had problems with fractured lead wires last winter, according to consumer advocacy group Public Citizen. These defects were reported to the government last winter. According to Dr. Sidney Wolfe, the FDA had received 599 reports of defibrillator malfunctions as of January 10,…

Joseph H. Saunders

Sprint Fidelis Defibrillator May Pose More Risk to Young

According to a Wall St. Journal article, the Medtronic Sprint Fidelis defibrillator may pose more risk to the young than previously thought. The Sprint Fidelis has had problems with its lead wire breaking causing erratic jolts of electricity to the heart. The wire connects the defibrillator to the heart and is supposed to jolt the heart rhythm back into a normal rhythm. However, the device…

Joseph H. Saunders

FDA Approves New Medtronic Stent in Spite of Report

In spite of a recent scientific report citing certain health risks, the FDA voted to approve Medtronic’s new cardiac stent, Endeavor. Data published a few days before the vote raised questions about the risk of blood clots linked to use of the drug coated stent. However, the FDA panel did suggest the FDA require that Medtronic conduct a 5 year post-approval study to assess the risks…

Joseph H. Saunders

Boston Scientific to Pay Settlement for its Guidant Defibrillator

The Boston Scientific Corporation has agreed to pay $195 million to approximately 4,000 people injured by the Guidant Ventak Prizm 2 Model 1861. The class action settlement was announced after the close of business yesterday and came on the heels of a federal trial that was to begin in 2 weeks. Judge Donovan W. Frank allowed the claims to go forward to trial and even stated that Boston…

Joseph H. Saunders

Bile Duct Stents Draw FDA Scrutiny

Th FDA wants to meet with the manufacturers of bile duct stents regarding their “off label” use for surgical applications. The stents are the latest drug or medical device to draw the attention of the FDA for inappropriate, or at least, unapproved use. The unapproved or off label uses comes as a direct result of the companies’ overly aggressive marketing tactics.

Joseph H. Saunders

Drug Coated Stents Prove Risky

In a recent medical study released by the Cleveland Clinic, drug coated stents manufactured by such companies as Boston Scientific and Johnson & Johnson have shown an increased risk for clots. With the older bare metal stents, tissue grows around and reclogs bare metal stents. Drug-eleuting stents prevent this growth but are now believed to increase the risk of blood clots.

Staff Writer

Is Florida Board of Medicine Too Easy on Docs?

An interesting editorial in the Palm Beach Post dated August 5, 2006, calls into question the existing system in place for monitoring Florida physicians for medical malpractice. Currently, the state of Florida has more than 50,000 licensed physicians, and the Department of Health reviews around 8,000 complaints by patients about doctors each year. The editorial accuses the state Board of…

Joseph H. Saunders

More Woes for Guidant

Fellow Injury Board blogger, James Sabatinihas a nice post on Guidant’s latest woes regarding their implantable cardiac defibrillators.

Joseph H. Saunders

Boston Scientific Issues New Warning on Defibrillators

Boston Scientific warned doctors that close to 1,000 of its cardiac implantable defibrillators may short circuit and fail to work properly leaving its patients vulnerable to cardiac problems. The company said that it learned of the failures after purchasing Guidant in April for $27.5 billion. U.S. regulators imposed sanctions on Guidant in December because of quality-control flaws after the…

Joseph H. Saunders

Doctors to Receive Guidelines on How to Handle Defective Defibrillators

A group that represents doctors, The Heart Rhythm Society, will publish guidelines to help doctors determine how to respond when a heart defibrillator malfunctions. The publication comes in response to problems experienced by cardiac defibrillator manufacturers,Guidant (recently acquired by Boston Scientific Corp.) and Medtronic. The guidelines call on device manufacturers to develop and use…