Evera XT VR Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Implantable Cardioverter Defibrillator (ICD) · First cleared Nov 2022 · 2 device variants grouped
Total Reports
954
Reports (30d)
0
Active Signals
0
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
3
reports
ICD Explanted Due to Infection
infection, event patient, patient complications, patient experienced, result event
1
reports
ICD Replaced for Premature Battery Depletion
icd remains, battery, icd exhibited, icd explanted, explanted replaced
1
reports
Fracture / Ventricular Lead / Lead Explanted
lead explanted, fracture, voltage, explanted replaced, ventricular lead
1
reports
Integrity / Lia / Alert Lia
integrity alert, lead integrity, alert lia, lia, integrity
1
reports
Result Event / Patient Complications / Event Patient
icd remains, event patient, patient complications, device remains, result event
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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
An unusual cause for inappropriate defibrillator shock
Debabrata Bera, et al. · Indian Pacing and Electrophysiology Journal · 2022
Effects of Irradiation During Computed Tomography Scanning on the Function of Implantable Cardioverter-defibrillators
YUSAKU NISHIKAWA, et al. · Journal of Innovations in Cardiac Rhythm Management · 2024
Safety of Contemporary Radiation Therapy in Patients With Cardiac Implantable Electronic Devices: Implications for Clinical Practice.
Karimzad K, et al. · Journal of the American Heart Association · 2025
Citations indexed from PubMed.
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