MEDTRONIC, INC. · Leadless Pacemaker · First cleared Apr 2016
Total Reports
2,316
Reports (30d)
148
Active Signals
2
Open Recalls
0
What the reports describe · Claripulse analysis
High Thresholds and Pacing Loss
implantable pulse, patient complications, generator ipg, result event, ipg
56
reports
Cardiac Perforation and Effusion
cardiac, patient complications, tamponade, generator ipg, ipg
44
reports
Intraoperative Non-Capture and Recapture Failure
delivery, implantable pulse, intraoperative, leadless implantable, ipg
43
reports
Incorrect RTC Value Post-Sterilization
time clock, clock, incorrect, rtc value, clock rtc
33
reports
Rising Thresholds One Week Post-Implant
implantable pulse, pulse generator, leadless implantable, generator ipg, ipg
32
reports
High Threshold and No Capture During Implant
implantable pulse, pulse generator, replaced implant, attempted used, ipg
30
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
Sudden Micra VR Battery Failure With Telemetry Loss and Fluoroscopic Battery Deformation
Yuya Nakamura, et al. · Pacing and Clinical Electrophysiology · 2025
Exertional Intolerance After a Leadless Pacemaker Implant: What Is the Mechanism?
James E. Ip · Pacing and Clinical Electrophysiology · 2025
Cardiac transplant-associated complete AV block treated with a leadless pacemaker: a case report
Débora Sá, et al. · European Heart Journal - Case Reports · 2025
Combined Lead Extraction and Leadless VDD Pacemaker Implantation in d-TGA Patient After Senning Procedure
Hamza Hamayel, et al. · JACC Case Reports · 2026
Different leadless pacemakers working in harmony (Aveir in the atrium/Micra AV2 in the ventricle) in a patient with dextrocardia and double outlet right ventricle after high‐risk infected device extraction
Carter English, et al. · Journal of Cardiovascular Electrophysiology · 2024
Citations indexed from PubMed.
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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 2 active signals detected right now.
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