Micra VR2 Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Leadless Pacemaker · First cleared Apr 2016
Total Reports
834
Reports (30d)
42
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
72
reports
Incorrect RTC Initialization at Manufacturing
clock, incorrect, data, pulse generator, ipg
4
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Wang D, et al. · European heart journal. Case reports · 2024
Kiblboeck D, et al. · Clinical research in cardiology : official journal of the German Cardiac Society · 2024
Micra Leadless Pacemaker Implantation via the Right Internal Jugular: Setup and Technique Insights
Maria Angelaki, et al. · The Journal of invasive cardiology/The journal of invasive cardiology · 2025
Device longevity of a leadless pacemaker family
Miguel A. Leal, et al. · Future Cardiology · 2025
Leadless Pacing: Current Status and Ongoing Developments
Richard G. Trohman · Micromachines · 2025
Citations indexed from PubMed.
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