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St. Jude Implanted Defibrillator Leads May Be Unsafe

August 21st, 2012

According to an article in The New York Times, Dr. Robert Hauser, a cardiologist who studies the safety of heart devices, is recommending that surgeons stop using a potentially dangerous device: St. Jude implanted defibrillator leads. A material used by St. Jude to coat the wires connecting a defibrillator to the heart is liable to break down, which could lead to failure of the devices.

This means that patients who depend on a defibrillator to put their heart back into normal rhythm may risk serious consequences, potentially even death, if the Optim wire coatings break down and “disconnect.”

Dr. Hauser told The New York Times:  “There is no need to use this lead until we have more confidence in its performance.”

According to Dr. Hauser’s research, the potentially dangerous abrasion and break-down can occur within 4 years of implantation.

According to the article, Dr. Hauser noted that:

…the study was limited because the F.D.A. database he used to collect the data is problematic. Information is often missing or incomplete, and the agency relies on physicians or hospitals to voluntarily report problems with medical devices. “Therefore, the number of lead failures in this study likely underestimates the actual number that has occurred,” he wrote in the study.

To read the full article in The New York Times, click here:  Cardiologist Warns About Safety of St. Jude Heart Device Component