What are the clinical consequences and causes of leadless pacemaker perforations reported in the MAUDE database?
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.
The Micra perforations reported in MAUDE are often associated with death and major complications requiring emergency intervention. Device and use problems account for at least half of perforations. Studies are needed to identify who is at risk for a perforation and how MACE can be avoided or mitigated.
Hauser et al. (Sat,) studied this question.