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Premature Notification System in Cardiac Monitor Leads Medtronic Australasia to Issue Hazard Alert

Mar 10, 2016
Image of Hazard Alert Cardiac Monitor

Hazard Alert for The Patient Using Insertable Cardiac Monitor Device

An Insertable Cardiac Monitor (ICB) is a small device that is implanted in the upper chest to continuously monitor heart rhythms and alert the wearer of any irregularities in the heart beat. The hazard alert is due to a defect in the device that Medtronic is currently in the process of correcting, by updating its software, the International Business Times reports.

Medtronic Australasia’s LINQ ICB device has a warning signal that is triggered to alert the patient that the battery is running out of power. The premature triggering of this alerting system is not affecting the battery, and the ICM would continue to function normally, reports the International Business Times. A press release from Therapeutics Good Administration, an agency within Australia’s Department of Health, announced that less than 4 percent of Medtronic’s patients with the implant are affected by the premature alert issue.

Usage of Recommended Replacement Time (RRT) alert

The Recommended Replacement Time (RRT) alert usually happens 200 days or 6 ½ months after the ICM is implanted. The insertion of the device is an outpatient procedure where the chest area is numbed with a local anesthetic, and the device is then inserted under the skin through a small incision. The patient remains conscious throughout the procedure, according to the International Business Times.

At the time the RRT alert is triggered, the device will continue to function, but 30 days later, a display: End of Service status appears, and will disable all automatic wireless alerts and transmissions. Remote transmissions could still be manually sent by the patient, to the doctor.

Need Legal Help Regarding Hazard Alert in Cardiac Monitor

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