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Evera MRI S DR SureScan Adverse Events: FDA MAUDE Data

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

Total Reports

608

Reports (30d)

2

Active Signals

0

Open Recalls

82

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Inappropriate ATP and Shock Delivery

svt, fibrillation, tachycardia, ventricular tachycardia, detected

5

reports

2

Premature Battery Depletion Observed

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

2

reports

3

RA Lead Undersensing During Atrial Events

fibrillation, atrial, atrial fibrillation, tachycardia, detected

2

reports

4

ICD Explanted with RV Lead Vegetation

implantable cardioverter, patient complications, event implantable, cardioverter defibrillator, result event

1

reports

5

Pocket Infection Leading to Explant

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

1

reports

6

Set Screw Issue During Implant

implantable cardioverter, atrial, replacement, cardioverter defibrillator, defibrillator icd

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

Shortland J, et al. · CJC pediatric and congenital heart disease · 2022

A rare case of delayed right atrial lead perforation in an adolescent patient with Brugada syndrome

Keerthana Banala, et al. · HeartRhythm Case Reports · 2024

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.