Abbott Medical ICDs and CRT-Ds

Consumers and health professionals are advised that Abbott Medical Australia, in consultation with the TGA, has issued a hazard alert for certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy defibrillators (CRT-Ds) due to two issues. Abbott Medical is also undertaking a product defect correction to update the firmware of these devices to address these issues.

ICDs are implantable medical devices that deliver electrical impulses to treat abnormal heart rhythms. CRT-Ds are ICDs that also coordinate the beating of the left and right ventricles to improve the heart’s blood pumping ability.

It has been identified that Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura and Unify Quadra devices manufactured between January 2010 and May 2015 are at risk of premature battery depletion.

The firmware update will enable those devices to detect abnormal battery performance due to lithium cluster-induced shorts. This will provide earlier notification of this issue, prior to premature battery depletion. Before this update, premature battery depletion could only be detected through remote monitoring and during routine follow-up evaluations. This firmware update provides a device-based Battery Performance Alert that will give a vibratory notification to the patient.

It has also been identified that the following high voltage device families, which use wireless radio frequency (RF) communication, Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura, Unify Quadra, Promote Quadra and Elllipse, are at theoretical risk of unauthorised access (also known as hacking).

The firmware update will provide additional security to reduce the risk of unauthorised access.

Please note that there have been no reports of these devices being compromised in this way. The United States Department of Homeland Security has advised the manufacturer that compromising the security of these devices would require a highly complex attack. If successful, an authorised person could gain access and give commands to the device through RF transmission, which could modify the device settings or impact functionality in a way that could pose a serious risk to the health of the patient.

The firmware updates will be available in Australia from the first week of June 2018.

Please note that all ICDs and CRT-Ds may require software changes from time to time, as technology and security of connected devices and associated systems continue to evolve. This is normal in terms of the life cycle of an electronic implantable medical device.

Information for consumers

If you or someone you provide care for has one of the affected models of Abbott Medical ICDs or CRT-Ds, please be aware of this issue.

If you have any questions or concerns, please speak to your health professional.

Information for health professionals

If you are treating a patient who has one of the affected models of Abbott Medical ICDs or CRT-Ds, please be aware of this issue.

If they have any further questions or concerns about this issue, refer them to their cardiologist.

Information for cardiologists

Abbott Medical has written to cardiologists who are managing the treatment of patients who have one of the affected models of Abbott Medical ICDs or CRT-Ds providing further information about this issue, including the upgrade process and patient management recommendations.

Prophylactic replacement of affected devices is not recommended.

Older generation devices (Current and Promote models) cannot receive the cybersecurity firmware update due to technology limitations. RF communication capabilities can be permanently disabled, but this is not recommended for most patients, as the patient would no longer be able to be remotely monitored.

If you have any questions about this issue, contact Abbott Medical on 1800 839 259.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information, see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.