Micra AV Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Leadless Pacemaker · First cleared Apr 2016
Total Reports
4,015
Reports (30d)
19
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
High Thresholds and Low Sensing at Implant
implantable pulse, pulse generator, leadless implantable, generator ipg, ipg
40
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Two-year outcomes of Micra AV leadless pacemakers in the Micra AV CED study
Mikhael F. El‐Chami, et al. · EP Europace · 2024
One-Year Outcomes of the First 1000 Patients Implanted With the Medtronic Micra AV Leadless Pacing System in France: The AV-CESAR Cohort Study
Fawzi Kerkouri, et al. · Circulation Arrhythmia and Electrophysiology · 2026
Micra leadless pacemaker revisions: incidence, characteristics, and outcomes from a multicentre French cohort
Peggy Jacon, et al. · EP Europace · 2025
Percutaneous extraction of a Micra AV transcatheter pacing system due to a rare sudden battery failure after 19 months from implantation: A first experience worldwide
Vincenzo Ezio Santobuono, et al. · Pacing and Clinical Electrophysiology · 2023
Micra AV leadless pacemaker implantation after transcatheter aortic valve implantation
Alexis Mechulan, et al. · Pacing and Clinical Electrophysiology · 2022
Citations indexed from PubMed.
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