Customer Communications
Premature RRT alert in some LINQ devices

Premature RRT alert in some LINQ devices

Reveal LINQ Model LNQ11
Original Date of Communication: February 2016

View specific models that this applies to

Product

All Reveal LINQTM Insertable Cardiac Monitor (ICM)

Advisory

Medtronic has identified an issue with the sensitivity of an algorithm used in the Reveal LINQ ICM that may prematurely trigger the Recommended Replacement Time (RRT) alert in some devices. As of February 12, 2016, Medtronic had observed an occurrence rate of 0.45% of devices experiencing this issue. Battery capacity is not affected and the device will continue to support data collection and manual data transmissions. As stated in Reveal LINQ labeling, the typical device will experience an average of 3 years longevity (refer to the device labelling for the corresponding use conditions).  As part of the normal behavior of the device, 30 days after RRT status is reached, Reveal LINQ devices will display an End of Service (EOS) status at which time the device disables automatic wireless alerts and transmissions. Thereafter, patients will still be able to send remote manual transmissions allowing clinics to receive alerts and stored device data.  Due to the design of the RRT algorithm, devices are not susceptible to this issue until 200 days (6.5 months) post-implant. As of February 12, 2016 the earliest reported occurrence of RRT is 7.3 months post-implant, with median implant to RRT duration of 16.5 months.   

Medtronic has obtained the necessary regulatory approvals to begin applying a software update to prevent and correct this issue in the field. Once installed, 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 follow-up care, patients' devices can receive the update via a programmer interrogation. Clinics with Reveal LINQ ICM patients will be contacted by Medtronic with instructions on how to install the update via the CareLink™ 2090 or Encore™ Programmer. Once programmers are updated, clinics will be provided further direction by their Medtronic Representative to contact patients who have experienced a premature RRT/EOS status in order to apply the update to individual Reveal LINQ ICMs. For new implants, the updated software will automatically be loaded on the Reveal LINQ ICM during interrogation of the device using a programmer that has previously been loaded with the new software.

As of December, 2016, patients also have the ability to receive this update via their MyCareLink™ Monitor, without the need to come into a clinic. Once the update has been installed on patients’ MyCareLink Monitor, the monitor itself will automatically apply the update to their Reveal LINQ ICM. 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.

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.



Specific Models This Applies To

www.medtronic.com/productperformance 951051