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Leadless Pacing Systems: Risk of Major Complications Related to Cardiac Perforation During Implantation - Letter to Health Care Providers

Today, the U.S. Food and Drug Administration (FDA) issued a Letter to Health Care Providers to remind them about the risk of major complications if cardiac perforation occurs during leadless pacemaker implantation.

Cardiac perforation is a rare complication of any pacemaker system implant and can lead to major complications or death. The FDA continues to evaluate real-world data which suggests that cardiac perforations associated with Medtronic Micra leadless pacemakers are more likely to be associated with serious complications, such as cardiac tamponade or death, than with traditional pacemakers.

The FDA is bringing this information to the attention of health care providers as a reminder and to encourage them to report leadless pacemaker cardiac perforations and complications related to perforation to the manufacturer and the FDA. The FDA is working with the manufacturer to evaluate information from all available sources on this issue.

Questions?

If you have questions, contact the Division of Industry and Consumer Education.