MEDTRONIC, INC. · Leadless Pacemaker · First cleared Apr 2016
Total Reports
3,917
Reports (30d)
18
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
High Threshold and No Capture During Implant
implantable pulse, pulse generator, replaced implant, attempted used, ipg
8
reports
High Thresholds and Pacing Loss
implantable pulse, patient complications, generator ipg, result event, ipg
8
reports
Cardiac Perforation and Effusion
cardiac, patient complications, tamponade, generator ipg, ipg
6
reports
Rising Thresholds Causing Battery Depletion
pulse, leadless implantable, generator ipg, ipg exhibited, ipg
5
reports
Literature Batch: IPG Implant Complications
complications, pericardial, patients, included, described
5
reports
High Thresholds and Loss of Capture
implantable pulse, pulse generator, leadless implantable, generator ipg, ipg
4
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
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
Strategies to improve atrioventricular synchrony in patients with a Micra AV leadless pacemaker
Christophe Garweg, et al. · EP Europace · 2024
Single-chamber atrial pacing + Micra AV implantation: A case report.
Cai Y, et al. · 2024
Micra leadless pacemaker revisions: incidence, characteristics, and outcomes from a multicentre French cohort.
Jacon P, et al. · 2025
Efficacy and safety of leadless ventricular pacemaker: a single-center retrospective observational study.
Yan L, et al. · 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. 1 active signal detected right now.
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