FDA-Device2018-01-31Class II
MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The monitor is an external electronic device that interfaces with Medtronic implanted heart devices and a telecommunications connection to transmit stored implanted heart device data to the physician or clinician.
Medtronic Inc., Cardiac Rhythm and Heart Failure
Hazard
Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network may have potential impact on the ability to remotely monitor the patient's heart devices. Potential impacts could lead to missed CareAlert notifications or device reports.
Sold states
Domestic: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Internationally: Austria, Belgium, Brunei, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kazakhstan, Latvia, Lithuania, Malaysia, Malta, Netherlands, Norway, Philippines, Poland, Portugal, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, United Kingdom
Affected count
1,519,984 enrollments total
Manufactured in
8200 Coral Sea St NE, N/A, Mounds View, MN, United States
Products
MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The monitor is an external electronic device that interfaces with Medtronic implanted heart devices and a telecommunications connection to transmit stored implanted heart device data to the physician or clinician.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0399-2018Don't want to check this manually?
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