ABBOTT ISSUES NEW UPDATES FOR IMPLANTED CARDIAC DEVICES

Updates part of ongoing effort to continuously improve patient care.

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Aug 29 2017

Abbott released updates to its implantable pacemakers and defibrillators as part of its ongoing commitment to continuously improve patient care.

The new device updates include a Battery Performance Alert for our implantable cardioverter defibrillators (ICDs) that provides physicians with earlier warning of the potential for the low risk of premature battery depletion. They also include a planned update to pacemaker firmware (a kind of software) to add additional security protections designed to reduce the risk of unauthorized access to patients' pacemakers.

About the Battery Performance Alert for Implantable Cardioverter Defibrillators

In October 2016, Abbott notified physicians and patients that a subset of ICD and cardiac resynchronization therapy defibrillator (CRT-D) devices manufactured between January 2010 and May 2015 could potentially experience premature battery depletion due to short circuits from lithium clusters.

The potential for premature battery depletion in the affected devices is low. The new Battery Performance Alert can be used as a tool to further assist in identifying the potential for these devices to experience premature battery depletion.

More detailed information on the Battery Performance Alert algorithm testing methods and performance can be found on our website www.sjm.com/batteryupdate.

About the New Pacemaker Firmware Update

The new pacemaker firmware update is part of Abbott's planned enhancements that began with updates announced in January 2017 to the Merlin@homeTM v8.2.2 software. The new updates provide an additional layer of security against unauthorized access to these devices.

The update contains a software release that includes data encryption, operating system patches, and the ability to disable network connectively features, in addition to the firmware update.

The pacemaker devices to which this update applies include the RF telemetry versions of the following devices in the U.S.: Accent SR RFTM, Accent MRITM, AssurityTM, Assurity MRITM, Accent DR RFTM, Anthem RFTM, Allure RFTM, Allure Quadra RFTM, and Quadra Allure MP RFTM.

Every pacemaker manufactured beginning Aug. 28, 2017, will have this update pre-loaded in the device and those devices will not need to be updated. Based on Abbott's consultation with the U.S. Food and Drug Administration, this update is being treated as a field action; however, the devices continue to function as intended and replacement of implanted pacemaker devices is not recommended.

For more information about the pacemaker firmware update, please contact our dedicated hotline at 1-800-722-3774 (U.S.) or visit our website at www.sjm.com/cyberupdate.

Read Abbott's statement here.

 

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