Sarasota Personal Injury Lawyer - Defective Medical Devices

Sprint Fidelis Pacemaker Had Problems Last Winter

Joe Saunders — Thu, 25 Oct 2007 08:13:37 GMT

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, 2007. Wolfe of Public Citizen asks a good question when he queries the FDA as to why it took so long to pull the plug on such a dangerously defective product as the Sprint Fidelis.

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Joe Saunders

Sprint Fidelis Defibrillator May Pose More Risk to Young

Joe Saunders — Fri, 19 Oct 2007 10:44:09 GMT

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 either send jolts of electricity when it is not needed or doesn't send them at all. The reason the device may be more dangerous in young people is that they tend to be more active and may make the defibrillator more susceptible to breakage.

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Joe Saunders

FDA Approves New Medtronic Stent in Spite of Report

Joe Saunders — Thu, 11 Oct 2007 05:31:09 GMT

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 potentially associated with the new cardiac stent.

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Joe Saunders

Boston Scientific to Pay Settlement for its Guidant Defibrillator

Joe Saunders — Sat, 14 Jul 2007 11:28:43 GMT

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 Scientific may be liable for punitive damages as a result of not disclosing to doctors and patients a serious defect in the heart defibrillator. Boston Scientific knew about the defect in 2002 and yet failed to disclose it until mid-2005.

For more information on this subject, please refer to our section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Joe Saunders

Bile Duct Stents Draw FDA Scrutiny

Joe Saunders — Wed, 14 Mar 2007 08:09:28 GMT

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.

Originally posted at InjuryBoard by Joe Saunders

Drug Coated Stents Prove Risky

Joe Saunders — Fri, 01 Dec 2006 09:27:10 GMT

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.

Originally posted at InjuryBoard by Joe Saunders

More Woes for Guidant

Joe Saunders — Tue, 23 May 2006 08:07:32 GMT

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

Originally posted at InjuryBoard by Joe Saunders

Boston Scientific Issues New Warning on Defibrillators

Joe Saunders — Wed, 17 May 2006 07:25:24 GMT

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 recall last year of 109,000 defibrillators linked to at least seven deaths. Many recalled devices were sold years after Guidant learned of the flaws and began making models free of the problem.

Originally posted at InjuryBoard by Joe Saunders

Doctors to Receive Guidelines on How to Handle Defective Defibrillators

Joe Saunders — Sat, 29 Apr 2006 08:31:30 GMT

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 wireless and remote monitoring technology to identify possible malfunctions or problems earlier.

Originally posted at InjuryBoard by Joe Saunders