bad medical devices blog

Nearly a year after Medtronic’s Sprint Fidelis Leads were recalled for shocking heart patients to death, the FDA announced today the approval of a software update from Medtronic that will help detect fractures of the company’s Sprint Fidelis cardiac defibrillator lead. The new software package’s purpose is to alert both patients and physicians of a […]

According to a Reuters report, a jolt from an implanted defibrillator is a very bad sign, as heart failure patients are about six times more likely to die after they receive their first life-saving shock, researchers reported on Wednesday. A study in the New England Journal of Medicine says 30 percent of those deaths come […]

Medtronic’s Infuse Bone Graft, a potent substance used in spine-repair surgery to promote bone growth, has been linked to life-threatening complications in dozens of patients. The Wall Street Journal reports that many of the potentially deadly reactions have occurred during “off label” uses, when surgeons use it in ways that haven’t been approved by the […]

The findings of a study funded by Boston Scientific reveal that surgery to clear clogged arteries is a more effective treatment than the use of propping stents.
The study followed about 1,800 patients faced with the prospect of either bypass surgery to unclog an artery, or to implant a stent to open it.
After one year, of […]

Reuters reports new techniques used for hip and knee replacements appear to need reworking at a higher rate than older methods, British researchers said on Tuesday. About one in 75 people needed to have their hip and knee replacements redone in the three years following the original procedure, according to the study published in the […]

The FDA has added thoracic aortic aneurysm stent grafts to the list of devices subject to tracking requirements, according to a final guidance released last week, the Wall Street Journal reports. The FDA may require tracking for Class II or III devices for which failure would probably have serious adverse health consequences, that are intended […]

A federal judge ruled that a family may proceed with its lawsuit against device manufacturers, saying preemption is not an issue in this case because the family’s claims are based on violations of federal law. Scott and Pamela Purcel filed suit last Sept. 27 against Advanced Bionics and Astro Seal in the U.S. District Court […]

In an age where information is a Google search away, the Food and Drug Administration is having a difficult time creating a national registry of implanted orthopedic joints.

Several other nations have such registries already begun, and the FDA has talked about starting such a registry, but when it comes time to actually compile it, it […]

A Monroeville, Pa. medical devices supplier has filed a lawsuit against six major device manufacturers, alleging they have attempted to corner the market through kickbacks to physicians.
Richard and Holly McCullough, owners of Intermedics-McCullough, believe payments totaling more than $8 million were attempts to persuade physicians into buying directly from the manufacturer and not do business […]

Boston Scientific has issued a Class I Recall of NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System, distributed from June 19, 2007, through May 5, 2008. The device is used in patients to treat a blockage in carotid artery disease. The product was recalled because the tip of the stent delivery system may detach […]