Micra Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Leadless Pacemaker · First cleared Apr 2016
Total Reports
5,464
Reports (30d)
120
Active Signals
3
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
High Threshold and Deployment Failure
implantable pulse, pulse generator, leadless implantable, generator ipg, ipg
108
reports
Pericardial Effusion During Repositioning
procedure surgery, stable condition, pericardial, effusion, presented implant
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Evidence
Related research
Lessons learned from Micra leadless pacemaker retrieval: a case series
Qi Guo, et al. · European Heart Journal - Case Reports · 2026
Micra leadless pacemaker revisions: incidence, characteristics, and outcomes from a multicentre French cohort
Peggy Jacon, et al. · EP Europace · 2025
Leadless pacemakers at 5-year follow-up: the Micra transcatheter pacing system post-approval registry
Mikhael F. El‐Chami, et al. · European Heart Journal · 2024
Two-year outcomes of Micra AV leadless pacemakers in the Micra AV CED study
Mikhael F. El‐Chami, et al. · EP Europace · 2024
Leadless vs. transvenous single-chamber ventricular pacing in the Micra CED study: 2-year follow-up
Mikhael F. El‐Chami, et al. · European Heart Journal · 2021
Citations indexed from PubMed.
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