Epsila EV Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Defibrillator Electrode (Lead) · First cleared Oct 2023
Total Reports
201
Reports (30d)
6
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Extravascular Lead P-Wave Oversensing
wave oversensing, extravascular lead, use, wave, oversensing
18
reports
ICD System Explanted for Infection
implantable cardioverter, infection, cardioverter defibrillator, defibrillator icd, result event
2
reports
Lead Explanted for Under-Sensing
revision, dislodgement, leads, reported lead, explanted replaced
1
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
Burright I, et al. · HeartRhythm case reports · 2025
Khoo KKL, et al. · HeartRhythm case reports · 2025
Inspiration-related sensing failure of extravascular cardioverter defibrillator
Stanisław Tubek, et al. · Kardiologia Polska · 2025
Duroi I, et al. · European heart journal. Case reports · 2025
Initial experience with the extravascular implantable cardioverter-defibrillator in pediatric patients
Mark P. Walsh, et al. · Heart Rhythm O2 · 2025
Citations indexed from PubMed.
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