Micra Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Leadless Pacemaker · First cleared Apr 2016
Total Reports
5,306
Reports (30d)
2
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
28
reports
Cardiac Perforation with Tamponade Risk
cardiac, tamponade, perforation, cardiac perforation, pericardial
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
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
Leadless versus transvenous single‐chamber ventricular pacemakers: 3 year follow‐up of the Micra CED study
George H. Crossley, et al. · Journal of Cardiovascular Electrophysiology · 2023
Assessing safety of leadless pacemaker (MICRA) at various implantation sites and its impact on paced QRS in Indian population
Prafull Sharma, et al. · Indian Heart Journal · 2020
Micra pacemaker in adult congenital heart disease patients: A case series
Pier Paolo Bassareo, et al. · Journal of Cardiovascular Electrophysiology · 2022
Comparison of the safety and efficacy of Nanostim and Micra transcatheter leadless pacemaker (LP) extractions: a multicenter experience
Tawseef Dar, et al. · Journal of Interventional Cardiac Electrophysiology · 2020
Citations indexed from PubMed.
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