The U.S. Food and Drug Administration (FDA) has released a warning about flaws in certain Medtronic implantable cardiac device programmers which could possibly be targeted by hackers to alter the functionality of the programmer during implantation or follow up visits. Around 34,000 vulnerable programmers are currently active.
The programmers are utilized by physicians to gather performance data, to review the status of the battery, and to reset Medtronic cardiac implantable electrophysiology devices (CIEDs) including pacemakers, implantable defibrillators, cardiac resynchronization devices, and insertable cardiac monitors.
The weaknesses are present in Medtronic CareLink 2090 and CareLink Encore 29901 programmers, specifically how the devices transmit to the Medtronic Software Distribution Network (SDN) online. The connection is necessary to download software updates for the programmer and firmware updates for Medtronic CIEDs.
While a virtual private network (VPN) is used to initiate a connection between the programmers and the Medtronic SDN, there is no check carried out to establish whether the programmer is still linked to the VPN before software updates are downloaded. This would give cyber attackers the chance to install their own updates and alter the functionality of the devices.
The weaknesses in the programmers were discovered by security researchers Billy Rios and Jonathan Butts in 2017. Medtronic was made aware of the flaws but has been slow to take action. An advisory was eventually released in February 2018, but it has taken until now for action to be taken to correct the flaw.
Medtronic is now stopping the programmers from connecting to the SDN to receive software updates. Instead, future updates must be completed by Medtronic through a USB connection. Any efforts to update the device via the SDN will now lead to an “Unable to connect to local network” or “Unable to connect to Medtronic” error message.
The FDA audited the cybersecurity vulnerabilities and has confirmed that the weaknesses could be exploited to cause patients to come under threat. On October 5, 2018, the FDA approved the Medtronic network update that obstructs the programmer from logging onto the Medtronic SDN.
The FDA recommends that the programmers persist in using it for programming, testing and evaluation of CIED patients. The internet connection is not necessary for normal operation.
Both the FDA and Medtronic have said that that no reports have been submitted to suggest that the flaws have been exploited.