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Evera XT VR Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · Implantable Cardioverter Defibrillator (ICD) · First cleared Nov 2022

Total Reports

642

Reports (30d)

4

Active Signals

0

Open Recalls

82

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

ICD Explanted Due to Infection

implantable cardioverter, infection, event patient, patient complications, event implantable

4

reports

2

Premature Battery Depletion Observed

implantable cardioverter, depletion, battery, cardioverter defibrillator, defibrillator icd

3

reports

3

Inappropriate ATP and Shock Delivery

svt, fibrillation, tachycardia, ventricular tachycardia, detected

2

reports

4

ICD Explanted for Unknown Reason

implantable cardioverter, crt, cardioverter defibrillator, defibrillator icd, icd explanted

1

reports

5

Pocket Infection Leading to Explant

implantable cardioverter, infection, pocket, cardioverter defibrillator, defibrillator icd

1

reports

6

RV Lead Integrity Alert Triggered

integrity alert, lead integrity, alert lia, lia, integrity

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

Class II

Oct 29, 2025 · Open, Classified

There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.

Class II

Apr 16, 2024 · Open, Classified

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Class II

Apr 16, 2024 · Open, Classified

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Class II

Apr 16, 2024 · Open, Classified

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Class II

Apr 16, 2024 · Open, Classified

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Class II

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

Bera D, 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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Understanding this data

What FDA MAUDE data does and does not tell you

How these reports are filed, why raw counts mislead, and the limits to know before drawing conclusions.

How a safety signal is detected

What the "Active Signals" count above means and the methods that separate a real signal from noise.

Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.