Vulnerability

Medtronic patches Bluetooth In-Office flaws between BlueSync pacemakers and SmartSync Device Manager

MedDevice Cyber Staff · Sep 10 · 3 min read · Via Medtronic security disclosure

Medtronic published a bulletin on September 10, 2020 on two vulnerabilities in the Bluetooth Low Energy communication between certain BlueSync cardiac devices and the CareLink SmartSync Device Manager Model 24970A. Affected implants are the Azure S DR MRI, Azure S SR MRI, Azure XT DR MRI and Azure XT SR MRI pacemakers and the Percepta, Serena and Solera CRT-P MRI and Quad CRT-P MRI devices.

The flaws could disrupt programming sessions and cause unintended battery drain. Medtronic states they cannot be used to change programming or intercept transmitted information.

Battery drain on an implant is a clinical cost because replacement means surgery. The fix belongs in the device clinic's queue even with programming integrity intact.

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Remediation Desk

For ProvidersOperators, hospitals, and clinical engineering

Apply the patch Medtronic released for the CareLink SmartSync Device Manager 24970A and BlueSync devices per its September 10, 2020 bulletin. Watch for unexpected battery drain on affected implants at follow-up.

Apply the BTIO patch. Update CareLink SmartSync Device Manager 24970A and affected devices as the bulletin directs.
Monitor battery longevity. Check battery status on affected Azure, Percepta, Serena and Solera implants at each follow-up.
Secure programmers. Keep SmartSync Device Managers under clinic control when not in use.

For Device ManufacturersAm I affected, and how to fix the class

Am I affected?

This class applies to devices with the signals and properties below. Check them against your product to gauge exposure. The named product rows list what the sources state about the affected product.

Required

Wireless connectivity

Contributing

Therapy delivery

Azure MRI pacemakers

Wireless connectivity

Percepta, Serena, Solera CRT-P MRI

Wireless connectivity

CareLink SmartSync Device Manager

Wireless connectivity

Fix the class in your product

Malformed or excessive input pushes the service over, and on a monitor that means the screen goes dark. As the maker, validate and bound every input at the boundary, handle malformed messages as a defined error path, and watchdog the clinical display so a fault recovers to a safe view.

Validate and bound input. Enforce type, size, and rate limits; null-check before you dereference.
Fail safe. Handle malformed input as a defined error path, never an unchecked dereference.
Watchdog the display. On a monitor, restore the clinical view quickly and safely after a fault.

Mapped EMB3D mitigations

Products potentially also affected

Products whose own public documentation shares this advisory's attributes. A shared attribute is a lead, not a finding. The status column shows only what each manufacturer has said.

Product	Manufacturer	Shared with this advisory	Manufacturer status
Assert-IQ (DM5000)	Abbott	Same FDA device type	No feedback feed from manufacturer
LUX-Dx II (M302); LUX-Dx II+	Boston Scientific	Same FDA device type	No feedback feed from manufacturer

Questions & Answers

What are the Medtronic BTIO Bluetooth vulnerabilities?

They are two flaws in the Bluetooth Low Energy link between BlueSync cardiac devices and the CareLink SmartSync Device Manager Model 24970A that could disrupt programming sessions and drain battery, disclosed September 10, 2020.

Can the BTIO vulnerability change pacemaker programming?

No. Medtronic stated on September 10, 2020 that the BTIO vulnerabilities in Azure, Percepta, Serena and Solera BlueSync devices cannot be used to change programming or intercept transmitted information.

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