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Sprint Quattro Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · Implantable Cardioverter Defibrillator (ICD) · First cleared Jan 2016

Total Reports

1,131

Reports (30d)

9

Active Signals

1

Open Recalls

82

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Lead Integrity Alert Triggered

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

3

reports

2

RV Lead High Thresholds Remain

lead remains, right ventricular, thresholds, use right, ventricular lead

2

reports

3

RV Lead Loss of Capture Observed

lead remains, lead exhibited, right ventricular, ventricular lead, capture

2

reports

4

RV Lead Explanted for Unknown Reason

lead explanted, atrial lead, right ventricular, right atrial, ventricular lead

2

reports

5

RV Lead High Defibrillation Impedance Observed

impedance, defibrillation, right ventricular, use right, ventricular lead

1

reports

6

Atrial Lead Undersensing During AF

fibrillation, atrial, undersensing, atrial fibrillation, tachycardia

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

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.