Medtronic Reveal LINQ insertable cardiac monitor

Hazard alert - potential for premature replacement alert

4 March 2016

Consumers and health professionals are advised that Medtronic Australasia, in consultation with the TGA, has issued a hazard alert for the Medtronic Reveal LINQ insertable cardiac monitor (ICM).

Medtronic Reveal LINQ ICM is a small medical device that is inserted just beneath the skin in the chest. It continuously monitors cardiac information and records the occurrence of abnormal heart rhythms. The device can automatically send this information to the doctor via wireless transmission.

It has been identified that the Recommended Replacement Time (RRT) alert of a small subset of these devices may trigger prematurely. However, battery capacity is not affected by this issue and the device will continue to work correctly.

Medtronic Reveal LINQ ICMs are normally expected to last an average of three years. Thirty days after an RRT alert triggers, the device will display an End of Service (EOS) status and automatic wireless alerts and transmissions are disabled. Patients can still send manual remote transmissions, which allow the doctor to continue to receive alerts and stored device data.

Please note that this issue is not expected to occur until at least 200 days (six and a half months) after implantation.

A software update is being prepared to address the premature RRT alert.

There have been no reports of complications or injuries as a result of this issue in Australia or overseas.

Information for consumers

If you or someone you care for has a Medtronic Reveal LINQ ICM, please be aware of this issue.

Medtronic Australasia estimates that fewer than 4% of patients who have a Medtronic Reveal LINQ ICM may experience a premature RRT alert.

If you receive an RRT alert on your device earlier than expected, speak to your health professional. Your device will continue to work correctly but you may be required to send remote manual transmissions or attend the clinic in person to allow your doctor to receive alerts and stored device data.

If you have any questions or concerns about this issue, contact your health professional.

Information for health professionals

If you are treating a patient who has a Medtronic Reveal LINQ ICM, advise them of this issue. Reassure them that, even if they receive a premature RRT alert, their device will continue to work correctly and that a software update is being prepared to correct this issue.

Medtronic Australasia estimates that fewer than 4% of patients will be affected by this issue.

If your patient continues to have questions or concerns about this issue, refer them to their managing cardiologist.

Information for cardiologists

Medtronic Australasia has written to cardiologists who manage patients with Medtronic Reveal LINQ ICMs, providing further information about this issue.

If you manage a patient who has a Medtronic Reveal LINQ ICM, advise them of this issue. Reassure them that, even if they receive a premature RRT alert, their device will continue to work correctly.

Prophylactic device replacement is not recommended and explant of devices that have experienced a premature RRT is not advised unless the loss of daily wireless transmission outweighs the risk of potential complications associated with explant surgery.

If you confirm that a patient has experienced a premature RRT alert and an EOS status is displayed, request that they submit manual remote transmissions or attend your clinic for programmer interrogation until the software update is complete.

If you have any questions or concerns about this issue, phone Medtronic Australasia on 02 9857 9000.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.