Epsila EV Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Defibrillator Electrode (Lead) · First cleared Oct 2023
Total Reports
236
Reports (30d)
0
Active Signals
2
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Extravascular Lead P-Wave Oversensing
lead remains, extravascular lead, use, extravascular, oversensing
20
reports
Extravascular ICD System Explanted for Infection
icd, infection, patient complications, extravascular, result event
4
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
Inspiration-related sensing failure of extravascular cardioverter defibrillator
Stanisław Tubek, et al. · Kardiologia Polska · 2025
Initial experience with the extravascular implantable cardioverter-defibrillator in pediatric patients
Mark P. Walsh, et al. · Heart Rhythm O2 · 2025
Successful implantation of an extravascular implantable cardioverter-defibrillator in a patient with moderate pectus excavatum: a case report.
Eaton H, et al. · European heart journal. Case reports · 2025
Implantation of an extravascular defibrillator with a preexisting endocardial dual-chamber defibrillator: When 2 defibrillators share 1 heart
Mathieu Echivard, et al. · HeartRhythm Case Reports · 2026
Citations indexed from PubMed.
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