Hazard Alert Issued for Medtronic’s Australasia Insertable Cardiac Monitor

Medtronic’s Reveal LINQ insertable cardiac monitor (ICM) was issued a hazard alert by Medtronic Australasia due to premature triggering of a notification system in the monitoring device warning that the battery was running out of power, International Business Times reports.

An insertable cardiac monitor is a small device, about the size of a key, that continuously monitors the heart and alerts the wearer of any abnormal heart rythms. Despite the premature alert, the device’s battery would not be affected, and the ICM would continue to function normally. Thirty days later, an End of Service status would be displayed, and all automatic wireless alerts and transmissions would be disabled. At that point, remote transmissions could still be manually sent by the patient to the doctor.

The monitor itself has approximately a 3-year lifespan and Medtronic is currently working on software to correct the premature alert issue. According to a press release from Therapeutics Good Administration, an agency under the Australian Department of Health, less than 4 percent of Medtronic patients with the implant will experience the premature alert problem.

The Recommended Replacement Time (RRT) alert normally happens six and one-half months, or 200 days, after the ICM is implanted. The insertion of the device is an outpatient procedure where the chest is numbed with a local anaesthetic, and the mechanism is then placed inside a small incision. The patient is conscious during the procedure and can communicate with the doctor, reports the International Business Times.

There have been no complications or injuries as a result of this issue, according to the Australian Government Department of Health website.

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