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FDA Warns Of Severe Risks Associated With Medtronic Leadless Pacemakers

Medtronic welcomes agency’s recommendations, highlights device’s safety record

 
• By Brian Bossetta

The US Food and Drug Administration has issued a warning to clinicians of the heightened risk for adverse events, including death, from potential cardiac perforation during implantation of Medtronic’s Micra Transcatheter Pacing System (TPS).

BEATING HEART
• Source: Alamy

In an advisory issued 17 November, the FDA reminded providers of potentially severe risks should cardiac perforation occur during surgery to implant Medtronic’s Micra TPS leadless pacemaker. Though rare, cardiac perforation is a dreaded adverse event that could result in life-threatening complications.

Traditional pacemakers have a lead wire that connects to the device’s generator via a vein to the heart’s ventricular wall. This lead connection delivers pulses to regulate the pumping of...

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• By Neena Brizmohun

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• By Ashley Yeo

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