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

MEDTRONIC, INC. · CRT-Defibrillator (CRT-D) · First cleared Jan 2019 · 2 device variants grouped

Total Reports

270

Reports (30d)

2

Active Signals

0

Open Recalls

78

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

AF with Rapid Response Triggering Inappropriate ATP and Shock

fibrillation, crt, atrial, ventricular, tachycardia

3

reports

2

Device System Explant for Infection

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

3

reports

3

Multilead Capture Loss with High Thresholds

crt, ventricular, impedance, high, resynchronization therapy

3

reports

4

Lead Noise and Oversensing from EMI

defibrillator crt, resynchronization, crt, ventricular, use

2

reports

5

CRT-D Explant for Unknown Reason

defibrillator crt, resynchronization, crt, resynchronization therapy, therapy defibrillator

1

reports

6

Loose Set Screw with Stripped Threads

defibrillator crt, resynchronization, crt, leads, resynchronization therapy

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

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

Cost-effectiveness analysis of cardiac implantable electronic devices with reactive atrial-based antitachycardia pacing

Takashi Noda, et al. · EP Europace · 2023

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.