MEDTRONIC, INC. · Leadless Pacemaker · First cleared Apr 2016
Total Reports
5,234
Reports (30d)
23
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Literature Batch: IPG Implant Complications
complications, pericardial, patients, included, described
27
reports
Dislodgement Due to Tether Cutting
implantable pulse, tether, replaced implant, leadless implantable, ipg
10
reports
High Thresholds and Pacing Loss
implantable pulse, patient complications, generator ipg, result event, ipg
9
reports
Rising Thresholds Causing Battery Depletion
pulse, leadless implantable, generator ipg, ipg exhibited, ipg
9
reports
Intraoperative Non-Capture and Recapture Failure
delivery, implantable pulse, intraoperative, leadless implantable, ipg
6
reports
High Threshold and No Capture During Implant
implantable pulse, pulse generator, replaced implant, attempted used, ipg
5
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
A leadless ventricular pacemaker providing atrioventricular synchronous pacing in the real-world setting: 12-Month results from the Micra AV post-approval registry
Christophe Garweg, et al. · Heart Rhythm · 2024
Two-year outcomes of Micra AV leadless pacemakers in the Micra AV CED study.
El-Chami MF, et al. · 2024
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
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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