Epsila EV MRI SureScan Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Defibrillator Electrode (Lead) · First cleared Oct 2023
Total Reports
1,530
Reports (30d)
21
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Extravascular Lead P-Wave Oversensing
extravascular lead, use, extravascular, result event, oversensing
128
reports
ICD System Explant Due to Infection
implantable cardioverter, icd, infection, cardioverter defibrillator, defibrillator icd
12
reports
Lead Explant Due to Oversensing and Shocks
lead capped, inappropriate, channel, oversensing, shocks
3
reports
Patient Expired with Unknown Cause
fibrillation, implantable cardioverter, icd, cardioverter defibrillator, defibrillator icd
2
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
Evaluation of a second-generation intercostal extravascular implantable cardioverter defibrillator lead with a pectoral pulse generator for sensing, defibrillation, and anti-tachycardia pacing
Shephal K. Doshi, et al. · EP Europace · 2025
Burright I, et al. · HeartRhythm case reports · 2025
New Horizons in Nontransvenous Arrhythmia Management: Aurora Extravascular ICD
Jonathan E. Tang, et al. · Journal of Cardiothoracic and Vascular Anesthesia · 2025
Citations indexed from PubMed.
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