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Crome DR MRI SureScan Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · Implantable Cardioverter Defibrillator (ICD) · First cleared Apr 2020

Total Reports

104

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

Inappropriate ATP and Shock Delivery

svt, fibrillation, tachycardia, ventricular tachycardia, detected

4

reports

2

ICD Explanted Two Weeks Post-Implant

infection, patient complications, complications, icd explanted, result event

1

reports

3

ICD Explanted with RV Lead Vegetation

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

1

reports

4

Pocket Infection Leading to Explant

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

1

reports

5

Premature Battery Depletion Observed

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

1

reports

6

RV Lead Capped and Replaced

tachycardia pacing, tachycardia, delivered, anti tachycardia, atp

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.

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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.