FDA Issues Warning About Flaws in Medtronic Implantable Cardiac Device Programmers

The U.S. Food and Drug Administration (FDA) has issued a warning about vulnerabilities in certain Medtronic implantable cardiac device programmers which could potentially be exploited by hackers to change the functionality of the programmer during implantation or follow up visits. Approximately 34,000 vulnerable programmers are currently in use.

The programmers are used by physicians to obtain performance data, to check the status of the battery, and to reprogram the settings on Medtronic cardiac implantable electrophysiology devices (CIEDs) such as pacemakers, implantable defibrillators, cardiac resynchronization devices, and insertable cardiac monitors.

The flaws are present in Medtronic CareLink 2090 and CareLink Encore 29901 programmers, specifically how the devices connect with the Medtronic Software Distribution Network (SDN) over the internet. The connection is required to download software updates for the programmer and firmware updates for Medtronic CIEDs.

While a virtual private network (VPN) is used to establish a connection between the programmers and the Medtronic SDN, there is no check performed to establish whether the programmer is still connected to the VPN before software updates are downloaded. This would give hackers the opportunity to install their own updates and alter the functionality of the devices.

The flaws in the programmers were identified by security researchers Billy Rios and Jonathan Butts last year. Medtronic was notified about the flaws but has been slow to take action. An advisory was eventually issued in February 2018, but it has taken until now for action to be taken to correct the vulnerability.

Medtronic is now preventing the programmers from connecting to the SDN to receive software updates. Instead, future updates must be performed by Medtronic through a USB connection. Any attempt to update the device via the SDN will now trigger an “Unable to connect to local network” or “Unable to connect to Medtronic” error message.

The FDA reviewed the cybersecurity vulnerabilities and has confirmed that the flaws could be exploited to cause patients to come to harm. On October 5, 2018, the FDA approved the Medtronic network update that blocks the programmer from accessing the Medtronic SDN.

The FDA recommends that the programmers continue to be used for programming, testing and evaluation of CIED patients. The internet connection is not a requirement for normal operation.

Both the FDA and Medtronic have confirmed that no reports have been received to suggest that the vulnerabilities have been exploited and no patients are known to have come to harm.

Author: Steve Alder has many years of experience as a journalist, and comes from a background in market research. He is a specialist on legal and regulatory affairs, and has several years of experience writing about HIPAA. Steve holds a B.Sc. from the University of Liverpool.