ALERT-Cybersecurity Vulnerabilities Affecting Medtronic Cardiac Devices

DE FAAKTO INTELLIGENCE RESEARCH OBSERVATORY

SITUATION-ALERT-U.S. FOOD & DRUG ADMINISTRATION

BACKGROUND-CYBERSECURITY VULNERABLITY MEDTRONIC CARDIAC DEVICES

Cybersecurity Vulnerabilities Affecting Medtronic Implantable Cardiac Devices, Programmers, and Home Monitors: FDA Safety Communication

Who does this Alert affect?

• Patients with a Medtronic cardiac implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds)
• Caregivers of patients with a Medtronic ICD or CRT-D
• Cardiologists, electrophysiologists, cardiac surgeons, and primary care physicians treating or managing patients with heart failure or heart rhythm problems using a Medtronic ICD or CRT-D

This is an extensive and detailed safety communication-IF THIS ALERT APPLIES TO YOU PLEASE REVIEW THE ALERT ON THE FDA WEBSITE

https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm633960?utm_campaign=%20Implantable%20Cardiac%20Devices%2C%20Programmers%2C%20and%20Home%20Monitors%20by%20Medtronic%3A%20Safety%20Communication&utm_medium=email&utm_source=Eloqua

The U.S. Food and Drug Administration (FDA) is issuing this safety communication to alert health care providers and patients about cybersecurity vulnerabilities identified in a wireless telemetry technology used for communication between Medtronic’s implantable cardiac devices, clinic programmers, and home monitors. The FDA recommends that health care providers and patients continue to use these devices as intended and follow device labeling.

Although the system’s overall design features help safeguard patients, Medtronic is developing updates to further mitigate these cybersecurity vulnerabilities. To date, the FDA is not aware of any reports of patient harm related to these cybersecurity vulnerabilities.

This communication does NOT apply to any pacemakers, cardiac resynchronization pacemakers (CRT-Ps), CareLink Express monitors, or the CareLink Encore Programmer (model 29901).

Affected Medtronic ICD and CRT-D device models include:

• Amplia MRI CRT-D, all models
• Claria MRI CRT-D, all models
• Compia MRI CRT-D, all models
• Concerto CRT-D, all models
• Concerto II CRT-D, all models
• Consulta CRT-D, all models
• Evera MRI ICD, all models
• Evera ICD, all models
• Maximo II CRT-D and ICD, all models
• Mirro MRI ICD, all models
• Nayamed ND ICD, all models
• Primo MRI ICD, all models
• Protecta CRT-D and ICD, all models
• Secura ICD, all models
• Virtuoso ICD, all models
• Virtuoso II ICD, all models
• Visia AF MRI ICD, all models
• Visia AF ICD, all models
• Viva CRT-D, all models

Affected Medtronic Programmer and Monitors models include:

• CareLink 2090 Programmer
• MyCareLink Monitor, models 24950 and 24952
• CareLink Monitor, Model 2490C