Micra AV2 Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Leadless Pacemaker · First cleared Apr 2016
Total Reports
2,835
Reports (30d)
119
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
241
reports
Incorrect RTC Initialization at Manufacturing
clock, incorrect, data, pulse generator, ipg
9
reports
Helix Fixation Failure During Implant
adverse, implanted resolve, resolve event, event patient, different
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Sudden Micra VR Battery Failure With Telemetry Loss and Fluoroscopic Battery Deformation
Yuya Nakamura, et al. · Pacing and Clinical Electrophysiology · 2025
Advancements in Leadless Pacemakers: What the Second-generation Micra AV2 Brings to Cardiac Care
Christophe Garweg, et al. · Heart International · 2024
Combined Lead Extraction and Leadless VDD Pacemaker Implantation in d-TGA Patient After Senning Procedure
Hamza Hamayel, et al. · JACC Case Reports · 2026
Cardiac transplant-associated complete AV block treated with a leadless pacemaker: a case report
Débora Sá, et al. · European Heart Journal - Case Reports · 2025
Citations indexed from PubMed.
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