CapSure Sense Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead), Permanent Defibrillator Electrode (Lead) · First cleared Jul 2002 · 2 device variants grouped
Total Reports
3,547
Reports (30d)
94
Active Signals
3
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
High Thresholds in RA Lead
thresholds lead, lead capped, lead attempted, lead lead, used replaced
15
reports
Undersensing During Atrial Events
termination, pacing times, tachycardia atrial, resulting termination, event patient
8
reports
Premature Battery Depletion in IPG
implantable pulse, right ventricular, pulse generator, generator ipg, ipg
7
reports
Undersensing in RA Lead
intermittent, undersensing resulting, unnecessary, exhibited undersensing, undersensing
7
reports
RA Lead Dislodged Post-Implant
lead explanted, implant right, lead dislodged, post implant, explanted replaced
6
reports
High Thresholds Post-Implant
implant right, approximately, exhibited high, post implant, high thresholds
6
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Evidence
Related research
Prevalence and management of electrical lead abnormalities in cardiac implantable electronic device leads
Hilary Roberts, et al. · Heart Rhythm O2 · 2023
Pacemaker lead fracture caused by strong lead bending in the pocket with the fixation of the generator in the low prothoracic position
Shun Akai, et al. · Journal of Cardiology Cases · 2024
When Pacing Fails After Generator Replacement: A Stepwise Diagnostic Approach to a Reversible Lead–Header Interface Problem
Fulvio Cacciapuoti, et al. · Reports — Medical Cases Images and Videos · 2026
Citations indexed from PubMed.
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