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AveirTM VR leadless pacemaker와 관련된 부정적인 사건: 식품의약국 MAUDE 데이터베이스 연구.

PMID: 37209414 · 2023-05-20

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학술지Journal of cardiovascular electrophysiology

연도2023-05-20

PMID37209414

초록

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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