FDA Warns of Risk of Cardiac Perforation with Medtronic’s Leadless Pacemaker

The FDA has issued a reminder to healthcare providers about the risk of cardiac perforation during implantation of Medtronic’s leadless Micra transcatheter pacemaker.

Data from premarket clinical studies suggested that major complications related to cardiac perforation “appeared to be more severe for patients who received a leadless pacing system compared to patients who received a transvenous pacemaker,” the agency said.

And real-world use “suggests that cardiac perforations associated with Micra leadless pacemakers are more likely to be associated with serious complications, such as cardiac tamponade or death, than with traditional pacemakers,” the agency said.