Evera MRI XT DR SureScan Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Implantable Cardioverter Defibrillator (ICD) · First cleared Aug 2022 · 2 device variants grouped
Total Reports
4,976
Reports (30d)
49
Active Signals
2
Open Recalls
82
What the reports describe · Claripulse analysis
Most commonly reported problems
Inappropriate ATP and Shock Delivery
svt, fibrillation, tachycardia, ventricular tachycardia, detected
47
reports
RA Lead Undersensing During Atrial Events
fibrillation, atrial, atrial fibrillation, tachycardia, detected
15
reports
ICD Explanted for Unknown Reason
implantable cardioverter, crt, cardioverter defibrillator, defibrillator icd, icd explanted
6
reports
ICD Explanted Due to Infection
implantable cardioverter, infection, event patient, patient complications, event implantable
6
reports
ICD Shock for Atrial Event Misclassification
implantable cardioverter, icd remains, patient complications, defibrillator icd, result event
6
reports
Potential EMI Affecting ICD Function
noise, implantable cardioverter, episode, cardioverter defibrillator, defibrillator icd
5
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
Toyohara K, et al. · Pacing and clinical electrophysiology : PACE · 2020
Toyoda S, et al. · JACC. Case reports · 2021
Citations indexed from PubMed.
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