March 25, 2019 – Medtronic has identified potential vulnerabilities to wireless technologies (Conexus telemetry) used to monitor certain ICDs, CRT-Ds, and programmers. Medtronic highlights that no cases of cyberattack, privacy breech, or patient harm have been observed or associated with these vulnerabilities.

Medtronic has identified potential vulnerabilities to wireless technologies (Conexus telemetry) used to monitor certain ICDs, CRT-Ds, and programmers. Medtronic highlights that no cases of cyberattack, privacy breech, or patient harm have been observed or associated with these vulnerabilities.

Medtronic recommends that physicians and their patients continue to use the devices and maintain standard follow-up procedures. The manufacturer is developing IT updates to mitigate these vulnerabilities and will inform patients and physicians when there is a regulatory approval of the updates. Medtronic’s notification to the field is now available. Read Medtronic Notification.

The U.S. Food and Drug Administration’s (FDAsafety communication is also available.

Topic

  • Regulatory
  • U.S. Food and Drug Administration (FDA)

Resource Type

  • Safety Alerts

Manufacturer

  • Medtronic

Device Type

  • ICDs & CRT-Ds
  • Other