OmniaSecure MRI SureScan Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Defibrillator Electrode (Lead) · First cleared Apr 2025
Total Reports
164
Reports (30d)
67
Active Signals
3
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Left Lead P-Wave Oversensing
left, wave oversensing, use, wave, oversensing
19
reports
Lead Over-Sensing Noise During Implant
attempted, lead implanted, stable, implant procedure, helix
15
reports
Right Ventricular Lead T-Wave Oversensing
oversensing twos, wave oversensing, use, use right, twos
11
reports
ICD System Explanted for Infection
implantable cardioverter, infection, cardioverter defibrillator, defibrillator icd, result event
5
reports
High Capture Thresholds Observed
thresholds, use, exhibited high, use right, capture
5
reports
Lead Integrity Alert Triggered
triggered, episodes, non, alert, integrity
5
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
Sanders P, et al. · Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2025
Regoli F, et al. · BMC cardiovascular disorders · 2019
Alasti M, et al. · Journal of arrhythmia · 2018
Citations indexed from PubMed.
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