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
5,007
Reports (30d)
35
Active Signals
1
Open Recalls
82
What the reports describe · Claripulse analysis
Most commonly reported problems
Inappropriate ATP and Shock Delivered
svt, tachycardia svt, tachycardia, ventricular tachycardia, detected
46
reports
Inappropriate ATP During Atrial Events
fibrillation, atrial, atrial fibrillation, tachycardia, detected
10
reports
ICD System Explanted for Unknown Reason
crt, lead explanted, icd explanted, ventricular lead, explanted replaced
6
reports
Result Event / Patient Complications / Event Patient
icd remains, event patient, patient complications, device remains, result event
5
reports
ICD Explanted Due to Infection and Bacteremia
infection, patient complications, event implantable, icd explanted, result event
4
reports
ICD Replaced for Premature Battery Depletion
icd remains, battery, icd exhibited, icd explanted, explanted replaced
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
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
Patel AS, et al. · HeartRhythm case reports · 2021
Toyoda S, et al. · JACC. Case reports · 2021
Sumitomo N, et al. · Heart and vessels · 2010
Toyohara K, et al. · Pacing and clinical electrophysiology : PACE · 2020
Citations indexed from PubMed.
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