FDA updates Safety Alert for St Jude defibrillators
Editor's Note
The Food and Drug Administration (FDA) on October 19 issued an updated Safety Alert for implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators by St Jude Medical.
Because batteries for the devices may fail earlier than expected, St Jude has made available a new battery performance management tool, Battery Performance Alert (BPA), which detects and notifies physicians of abnormal battery performance that may lead to premature battery depletion.
If a BPA is triggered for a patient’s device, the physician will be notified through the device programmer and/or the Merlin@home monitoring system. If triggered, St Jude recommends immediate device explant and replacement.
UPDATED 10/19/2017. On August 28, 2017, St. Jude Medical notified physicians of the availability of Battery Performance Alert (BPA), a new battery performance management tool that detects and notifies physicians of abnormal battery performance that may lead to premature battery depletion in Implantable Cardioverter Defibrillators.
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