Leadless pacemaker perforations: Clinical consequences and related device and user problems
Why the study?
What are the clinical consequences and causes of leadless pacemaker perforations reported in the MAUDE database?
Population
Micra perforations reported in MAUDE
Authors
Discussion
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Member takes
Implication
Signals need for vigilance with leadless pacemakers; leaves open modifiable risk factors for prospective study.
Structured PICO
What are the clinical consequences and causes of leadless pacemaker perforations reported in the MAUDE database?
P
Population
Patients with leadless pacemaker (Micra) perforations reported in the MAUDE database
I
Intervention
Leadless pacemaker (Micra)
O
Outcome
Death and major complications requiring emergency interventionsafety
Analysis of adverse event reports indicates that leadless pacemaker perforations are frequently associated with severe complications and death, often driven by device and user problems.
Cite This Study
Hauser et al. (2021) studied this question.