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This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified — do not attempt re-identification. © 2026 Claripulse.

Back to Cardiac Rhythm Management

MAUDE Lookup Cardiac Rhythm ManagementCrome HF Quad CRT-D MRI SureScan

Crome HF Quad CRT-D MRI SureScan Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · CRT-Defibrillator (CRT-D) · First cleared Jan 2019

Total Reports

110

Reports (30d)

4

Active Signals

1

Open Recalls

78

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

CRT Device Explanted Due to Infection

cardiac resynchronization, crt, infection, patient complications, result event

3

reports

2

CRT Explanted for Unspecified Reason

defibrillator crt, cardiac resynchronization, resynchronization therapy, therapy defibrillator, crt explanted

1

reports

3

Dislodged Left Ventricular Lead During Implant

left, left ventricular, ventricular lead, used, implant procedure

1

reports

4

Inappropriate Therapy for Tachycardia

crt, atrial, therapy, tachycardia, ventricular tachycardia

1

reports

5

Infection with Device Pocket Erosion

explanted, icd, infection, pocket, ventricular lead

1

reports

Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.

Detection

Active safety signals

Disproportionate reportinghigh

Regulatory

FDA recalls for this device

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.

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

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.