www.fdanews.com/articles/178825-st-judes-heart-battery-malfunction-leads-to-two-deaths
St. Jude’s Heart Battery Malfunction Leads to Two Deaths
October 11, 2016
St. Jude Medical has issued a warning of the possibility that a battery issue could restrict its high-voltage cardiac rhythm management devices and that the problem has been linked to two deaths.
The device has a risk of the lithium-based batteries used in St. Jude’s implantable cardioverter defibrillators and cardiac rhythm-managment therapy devices could form “lithium clusters” during high-voltage charging. The clusters could then cause a short circuit and deplete the battery, making the device ineffective.
The problem affects ICDs and CRT-Ds made before May 23, 2015, the company said. — Cynthia Jessup