Healthcare Professionals

Medtronic CareLink Network

for Cardiac Device Patients

Indications, Safety, and Warnings

  

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Brief Statement: Medtronic MyCareLink™ Patient and CareLink® Monitors, Medtronic CareLink Express™ Monitor, Medtronic CareLink® Network, Medtronic CareLink™ Mobile Application, Medtronic CareLink™ Patient Information Site, Medtronic CardioSight Reader and Medtronic Programmer

These products are not a substitute for appropriate medical attention in the event of an emergency. Data availability, alert notifications, and patient messages are subject to internet connectivity and access, and service availability. The CareLink and MyCareLink Patient Monitors must be on and in range of the device. Physician alert notifications are not intended to be used as the sole basis for making decisions about patient medical care.

Brief Statement: Medtronic MyCareLink™ Patient and CareLink® Monitors, Medtronic CareLink Express™ Monitor, Medtronic CareLink® Network, Medtronic CareLink™ Mobile Application, Medtronic CareLink™ Patient Information Site, Medtronic CardioSight Reader and Medtronic Programmer

Intended Use

The MyCareLink Patient Monitor, CareLink Monitor, CareLink Express Monitor, and CareLink Network 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 Express Monitor is for use in a clinical setting with Medtronic implantable cardiac devices. 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. The CareLink Patient Information Site is intended to provide patients, their friends / family and caregivers messages regarding transmission status of patient device diagnostic data to the CareLink Network. The CardioSight Reader is intended for use in a clinical setting and indicated for use to interrogate compatible Medtronic implantable devices to collect patient and device data and send the information to the clinician. The CardioSight Reader cannot be used to change therapy. 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 and CareLink Patient Information Site 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 for the CareLink Mobile App and subject to coverage availability. Standard text message and data rates apply. Message frequency depends on account settings and clinic scheduling.

For US Text SMS Messages:

  • Visit www.myMedtronicCareLink.net to receive text messages by enrolling to our Short code 53671.
  • Reply HELP for text message Help (Non-Medical information regarding text messaging)
  • Reply STOP to cancel the text messages. Alternatively the user can change account settings via the CareLink Patient Information Site: www.myMedtronicCareLink.net
  • User must be 18 years or older or have permission from a parent or guardian to participate. *Terms and Conditions are available at www.myMedtronicCareLink.net
  • Supported Text Message Carriers: Our participating carriers include (but not limited to): AT&T, Sprint, Boost, Verizon Wireless, U.S. Cellular®, T-Mobile®.

Web browsers currently supported by the CareLink Patient Information Site are: Microsoft® Internet Explorer for Windows Version 8.x and Version 9.x, Mozilla Firefox® for Windows Version 13.x, Google Chrome™ for Windows Version 20.x.

Contraindications

There are no known contraindications.

Warnings and Precautions

The MyCareLink Patient Monitor, CareLink Monitor and CareLink Express Monitors and Reader must only be used for interrogating compatible Medtronic implantable devices. Do not use a cellular phone while the antenna is positioned over the implanted device. The CareLink Monitor, CareLink Express Monitor and CardioSight Reader are intended for use within the prescribing country.

Brief Statement: 2090 Programmer

The Medtronic CareLink programmer system is comprised of prescription devices indicated for use in the interrogation and programming of implantable medical devices. Prior to use, refer to the Programmer Reference Guide as well as the appropriate programmer software and implantable device technical manuals for more information related to specific implantable device models. Programming should be attempted only by appropriately trained personnel after careful study of the technical manual for the implantable device and after careful determination of appropriate parameter values based on the patient's condition and pacing system used. The Medtronic CareLink programmer must be used only for programming implantable devices manufactured by Medtronic or Vitatron.

See the device manuals for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1 (800) 929-4043 and/or consult Medtronic’s website at www.medtronic.com.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

Paceart System

Brief Statement: 9529 Reveal® XT and 9528 Reveal® DX Insertable Cardiac Monitors

InSync Sentry® Models 7297/7299, Concerto® Model C154DWK, Virtuoso® Models D154AWG/D154VWC (DR/VR), CONSULTA® Model D224TRK (CRT-D), Secura® Models D224DRG (DR) and D224VRC (VR)

IPG, ICD, CRT-D, CRT-P