Aurora EV-ICD MRI SureScan Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Implantable Cardioverter Defibrillator (ICD) · First cleared Oct 2023
Total Reports
634
Reports (30d)
36
Active Signals
1
Open Recalls
82
What the reports describe · Claripulse analysis
Most commonly reported problems
Pocket Infection Leading to Explant
implantable cardioverter, infection, pocket, cardioverter defibrillator, defibrillator icd
20
reports
Inappropriate Shock Inducing VF
fibrillation, high voltage, tachycardia, ventricular tachycardia, inappropriate
14
reports
High Pacing Impedance During Testing
implantable cardioverter, defibrillation, testing, cardioverter defibrillator, defibrillator icd
12
reports
Inappropriate ATP and Shock Delivery
svt, fibrillation, tachycardia, ventricular tachycardia, detected
6
reports
Potential EMI Affecting ICD Function
noise, implantable cardioverter, episode, cardioverter defibrillator, defibrillator icd
4
reports
ICD Removal Due to Infection
implantable cardioverter, patient complications, event implantable, cardioverter defibrillator, result event
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Regulatory
FDA recalls for this device
Oct 29, 2025 · Open, Classified
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
Apr 16, 2024 · Open, Classified
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Apr 16, 2024 · Open, Classified
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Apr 16, 2024 · Open, Classified
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Apr 16, 2024 · Open, Classified
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Apr 16, 2024 · Open, Classified
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Evidence
Related research
Kerley RN, et al. · Journal of cardiovascular electrophysiology · 2026
Intercentre heterogeneity and determinants of implantable cardioverter-defibrillator technology selection in France
Fawzi Kerkouri, et al. · Archives of cardiovascular diseases · 2026
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
Extravascular ICD as a Viable Solution After CIED Lead Extraction: A Case Report
Giuseppe Coppola, et al. · Pacing and Clinical Electrophysiology · 2025
New Horizons in Nontransvenous Arrhythmia Management: Aurora Extravascular ICD
Jonathan Tang, et al. · Journal of Cardiothoracic and Vascular Anesthesia · 2025
Citations indexed from PubMed.
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