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PubMed

Adverse events associated with AveirTM VR leadless pacemaker: A Food and Drug Administration MAUDE database study.

PMID: 37209414 ·

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JournalJournal of cardiovascular electrophysiology
Year
PMID37209414

Abstract

Leadless pacemaker (LP) offers an innovative approach for treating bradyarrhythmia, thus avoiding pacemaker pocket and lead-related complications. The Food and Drug Administration (FDA) has recently approved the Aveir™ leadless pacing system (screw-in type LP). We queried the FDA MAUDE database to study the safety profile and assess the types of complications with this relatively novel device technology. A MAUDE database search was conducted on January 20, 2023, for reports received post-FDA app

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