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St. Jude warns batteries in up to 350,000 defibrillators could fail

Staff Writer |
St. Jude Medical said 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.

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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. It is a rare occurrence of 0.21 percent.

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.

Some defibrillators can also serve as pacemakers, and that function is disrupted by a battery failure as well.


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