Awful. The problems in the world just keep cascading at every level, in every industry.

Via Star Trib.

Following deaths and injuries worldwide, Minnesota-based heart device maker St. Jude Medical announced Tuesday that nearly 350,000 of its defibrillators implanted in patients may be prone to short-circuiting in a way that causes the device to fail unexpectedly.

Two deaths have been associated with situations where the devices failed to send lifesaving shocks to the heart, including one death in the U.S. In addition, 10 people have fainted and 37 more have reported dizziness after their defibrillators failed to keep their hearts beating in proper rhythm.

“While it is a rare occurrence (0.21 percent), we want to ensure we are providing the information physicians need to best care for their patients,” a St. Jude spokeswoman said in an e-mail regarding the rate of device failures. “We have asked physicians to contact their patients with information about this advisory. Device replacement is not recommended unless the physician determines otherwise.”

Just hours before a Food and Drug Administration alert on the failures was published Tuesday morning, St. Jude announced that it had detected the potential for premature battery depletion in a wide swath of its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).

The at-risk models include various models of: Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura, and Unify Quadra devices. The defect has only been detected in devices made before May 2015.


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