Epsila EV MRI SureScan Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Defibrillator Electrode (Lead) · First cleared Oct 2023
Total Reports
1,526
Reports (30d)
85
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Extravascular Lead Oversensing
lead remains, extravascular lead, use, extravascular, oversensing
147
reports
Extravascular ICD Explanted for Infection
icd, infection, patient complications, extravascular, result event
17
reports
Lead Explanted for Oversensing and Shock
received file, lead capped, inappropriate, channel, oversensing
1
reports
Patient Expired with Unknown Cause
implantable cardioverter, tachycardia, cardioverter defibrillator, defibrillator icd, implant procedure
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Khoo KKL, et al. · HeartRhythm case reports · 2025
Burright I, et al. · HeartRhythm case reports · 2025
Initial Experience of the Medtronic Aurora Extravascular Implantable Cardioverter in Children in a UK Centre
Georgia Spentzou, et al. · Pediatric Cardiology · 2025
Citations indexed from PubMed.
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