Important Safety Information
Bradycardia (Slow Heart Rate)
Implantable Pacemaker System
Additional Device Information
An implantable pacemaker system relieves symptoms of heart rhythm disturbances. They do this by restoring normal heart rates. A normal heart rate provides your body with the proper amount of blood circulation. The pacemaker system is intended for patients who need rate-adaptive pacing or chronic pacing or for patients who may benefit from synchronizing the pumping of the heart chambers.
Risks associated with pacemaker system implant include, but are not limited to, infection at the surgical site and/or sensitivity to the device material, failure to deliver therapy when it is needed, or receiving extra therapy when it is not needed. After receiving an implantable pacemaker system, you will have limitations with magnetic and electromagnetic radiation, electric or gas powered appliances, and tools with which you are allowed to be in contact.
This treatment is prescribed by your physician. This treatment is not for everyone. Please talk to your doctor to see if it is right for you. Your physician should discuss all potential benefits and risks with you. Although many patients benefit from the use of this treatment, results may vary.
Medtronic Patient/Home Monitor
Additional Device Information
The Medtronic CareLink, MyCareLink, MyCareLink Smart Patient Monitors, MyCareLink Heart Application, Medtronic CareLink Network, and the CareLink Mobile Application are indicated for use in the transfer of patient data from Medtronic implantable cardiac devices. These products are not a substitute for appropriate medical attention in the event of an emergency. Data availability and alert notifications are subject to Internet connectivity and access, and service availability. The CareLink and MyCareLink Patient Monitors and the MyCareLink Smart Reader must be on and in range of the device. The MyCareLink Smart Reader must also be within range of the user mobile device. CareLink and MyCareLink alert notifications are not intended to be used as the sole basis for making decisions about patient medical care.
Brief Statement: Medtronic CareLink®, MyCareLink®, MyCareLink Smart™ Patient Monitors, MyCareLink Heart™ Application, Medtronic CareLink® Network and CareLink® Mobile Application
Intended Use
The Medtronic CareLink, MyCareLink, MyCareLink Smart Patient Monitors, MyCareLink Heart Application, CareLink Network and the CareLink Mobile Application are indicated for use in the transfer of patient data from some Medtronic implantable cardiac devices based on physician instructions and as described in the product manual. The CareLink Mobile Application is intended to provide current CareLink Network customers access to CareLink Network data via a mobile device for their convenience. The CareLink Mobile Application is not replacing the full workstation, but can be used to review patient data when a physician does not have access to a workstation. These products are not a substitute for appropriate medical attention in the event of an emergency and should only be used as directed by a physician. CareLink Network availability and mobile device accessibility may be unavailable at times due to maintenance or updates, or due to coverage being unavailable in your area. Mobile device access to the internet is required and subject to coverage availability. Standard text message rates apply.
Contraindications
There are no known contraindications.
Warnings and Precautions
The CareLink, MyCareLink and MyCareLink Smart Patient Monitors must only be used for interrogating compatible Medtronic implantable devices. Additionally, the CareLink and MyCareLink Monitors are intended for use within the prescribing country. The MyCareLink Smart Patient Monitors may be used internationally. Standard mobile device availability and rates apply.
See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential complications/adverse events.
Caution: Federal law (USA) restricts this system to sale by or on the order of a physician.