April 23, 2018 – Abbott recently notified physicians about the availability of new device firmware to further strengthen the security and improve the performance of our high voltage (HV) implantable cardiac devices (ICDs and CRT-Ds).
As communicated in August 2017, the BPA algorithm is a management tool and is intended to provide earlier notification of abnormal battery performance for Battery Advisory Devices prior to premature battery depletion. Until now, detection of this alert has only been available through the Merlin.net™ remote monitoring system and the Merlin™ programmer during routine follow-up evaluations. This firmware upgrade now allows for device-based detection of abnormal battery performance and if BPA is triggered, a vibratory notification is delivered to the patient, thereby ensuring continuous monitoring in situations where adherence to transmission schedules is challenging (e.g. travel). Additionally, an alert will still continue to be provided to physicians through the Merlin.net™ remote monitoring system and the Merlin™ programmer during subsequent follow-up.
August 29, 2017 – As part of Abbott’s commitment to continuous improvement, we have recently released an update intended to provide physicians with earlier warning of the potential for premature battery depletion due to short circuits from lithium clusters in patients’ implantable defibrillators.
The new Battery Performance Alert, which can be used as a patient management tool and is intended to help identify potential premature battery depletion in the following devices subject to the October 11, 2016 Medical Device Advisory: Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™, and Unify Quadra™.
On October 10, 2016, St. Jude Medical provided an Important Medical Device Advisory to physicians regarding the St. Jude Medical ICD and CRT-D devices manufactured before May 23, 2015 for models Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™ and Unify Quadra™:
April 16, 2018 Update – Abbott has developed online information for patients, located here. The page includes important information about the new Battery Performance Alert update and responses to frequently asked questions. Patients can also look up their serial numbers for their devices and learn more about remote monitoring options.