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The U.S. Food and Drug Administration (FDA) recently released a warning reminding healthcare providers about the risks associated with the Medtronic Micra leadless pacemaker system. The FDA encouraged doctors to be aware that the risks may be higher in patients who receive leadless pacing systems vs. traditional transvenous pacemakers.

How the Medtronic Micra Leadless Pacemaker is Different

Pacemakers are surgically implanted devices that generate electrical impulses to treat slow pulse rates. A traditional pacemaker has a “lead” that extends from the pacemaker generator—which is implanted under the skin near the collarbone—through a vein and to the heart’s right ventricular wall. The lead delivers electric pulses from the generator to coordinate the timing of the heartbeat.

Pacemaker leads can sometimes malfunction or cause infections in the surrounding tissues. A Medtronic Micra leadless pacemaker system does not have this type of lead. Instead, the pacemaker itself is implanted directly in the right ventricle chamber of the heart.

The FDA first approved this new system—the first that didn’t require wired leads—in April 2016. Though the system works like other pacemakers to regulate heart rate, it is self-contained and only about an inch long.

FDA Warns that Complications of Cardiac Perforation More Serious with Medtronic

The reason the FDA is reminding healthcare providers about the risks associated with the Medtronic Micra leadless pacemaker system is because of problems that may occur during implantation.

Should the surgeon perforate the heart somehow while implanting the pacemaker, complications can be serious. Though the risk of perforation seems to be similar between the Medtronic Micra and traditional pacing systems, the complications with the Micra may be more severe.

Since 2016, the FDA has received over 300 medical reports for the Micra leadless system that describe a perforation, and over 90 of these resulted in death.

While perforation typically happens during implantation, complications can develop days, weeks, or even months afterward. Fluid may build up around the heart, requiring drainage with a catheter or surgical repair.

According to the FDA, Medtronic Micra leadless pacemaker premarket clinical studies “suggested 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 FDA is continuing to evaluate this issue, but at this point has found that Micra pacemakers are more likely to be associated with cardiac tamponade (pressure on the heart caused by fluid buildup) or death than other pacemakers.

FDA Advises Caution in Surgeons

The FDA suggested that healthcare providers discuss the risks and benefits of the available pacemaker systems with their patients before implantation. Although cardiac perforation is a rare complication of pacemaker implants, the risk may be higher in those receiving leadless systems.

The FDA also recommended that surgeons read and carefully follow the instructions for use and training with the Medtronic system, and to report any adverse events to the FDA’s adverse event reporting system.

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