October 23, 2017

FDA updates Safety Alert for St Jude defibrillators

By: Judy Mathias
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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.

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