Medtronics Australasia issues hazard alert for insertable cardiac monitor

Medtronics Australasia issued on Friday a hazard alert for its Medtronic Reveal LINQ insertable cardiac monitor (ICM). The alert is because of premature triggering of the Recommended Replacement Time (RRT) notification ahead of the battery running out of power.

The ICM is a small medical device inserted under the skin in the chest. It provides continuous monitoring of cardiac information and also records when abnormal heart rhythms happen. The information could be automatically sent to the cardiologist of the patient through wireless transmission.

Despite the premature RRT alert, the device’s battery capacity is not affected, and the ICM would continue to function. When the RRT alert is triggered, the gadget will continue to function, but after 30 days, it would display an End of Service status, disabling all automatic wireless alerts and transmissions. However, patients could still send remote transmissions manually to the doctor.

The RRT alert normally takes place at least 200 days, or six and a half months after the ICM is implanted. To insert the device, the chest area is numbed with local anaesthesia and a small incision is made where the monitor is inserted. The patient is awake and could communicate with the doctor or nurse during the outpatient procedure, according to Medtronics.

The device itself has a lifespan of three years. To address the premature RRT alert issue, Medtronics says that a software update is being prepared. Less than four percent of Medtronics patients with the implant experience the premature RRT alert problem, according to the press release of Therapeutics Good Administration, an agency under the Australian government’s Department of Health.

Doctors have been advised to inform their patients with the ICM of the problem. Medtronics discourages prophylactic replacement of the gadget and advises against explanting the ICM unless the loss of daily wireless transmissions outweigh the risk of potential complications linked with the procedure.