Physician Letter

Physician Letters (PDF)

Device Identification

UPDATE TO MEDICAL DEVICE CORRECTION Software Update Now Available via MyCareLink™ Patient Monitor

Reveal LINQ™ Insertable Cardiac Monitor (ICM)
Model LNQ11

 

November 2016

Dear Physician or Healthcare Professional,

In May 2016, Medtronic issued an Update to Medical Device Correction communication that indicated Medtronic was ready to begin applying a software update to Reveal LINQ™ Insertable Cardiac Monitors (ICMs). This update, applied via Encore and 2090 Programmers, addressed a performance issue that affects the Recommended Replacement Time (RRT) alert. This original communication also explained that Medtronic was working on functionality to allow patients the ability to receive this update via their MyCareLink™ Patient Monitor. This update through the MyCareLink Monitor is now ready for deployment.

What is the purpose of this software update?
This MyCareLink Monitor functionality will allow a patient to receive the updated Reveal LINQ RRT software via their home monitor without the need to come into a clinic. Once installed on a Reveal LINQ ICM, this software update will reset RRT & End of Service (EOS) status and re-enable wireless transmissions for devices that have experienced premature RRT / EOS. The update will also prevent the occurrence of premature RRT alerts due to this issue.

How do clinics apply this update to Reveal LINQ ICMs?
During the course of their normal monitoring and follow-up care, patients' devices can receive the update via a programmer interrogation or home monitor manual transmission. Once the update has been installed on patients' MyCareLink Monitor, the monitor itself will automatically apply the update to their Reveal LINQ ICM during a subsequent manual transmission. If your patient's Reveal LINQ ICM is at RRT / EOS, instruct them to complete the following activities to order to receive the update as quickly as possible:

  1. Unplug the MyCareLink Patient Monitor from the wall outlet, wait 10 seconds, and then plug it back in.
  2. Leave your MyCareLink Patient Monitor plugged in and untouched for 24 hours to allow software updates to be successfully installed.
  3. After 24 hours have elapsed, complete a manual transmission using your MyCareLink Patient Monitor.

Patients who are not actively monitored using a MyCareLink Monitor or are using an analogue adaptor to connect to the CareLink Network will need to come into the clinic for interrogation by a programmer that has previously been loaded with the RRT software update.

How can I get more information on this update?
Additional information, including direction on how to apply this update, can be found at MedtronicDiagnostics.com/us/linq-software-update or by contacting your Medtronic Representative. Medtronic Diagnostic Patient Services is available to assist patients at 800-929-4043. If you have any questions, or if we can be of further assistance, please contact your local Medtronic Representative or Medtronic Diagnostic Technical Services at 800-929-4043.

Sincerely,

Tim Samsel

Tim Samsel

Vice President, Quality and Regulatory
Medtronic Cardiac Rhythm Heart Failure