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Sprint Quattro Secure MRI SureScan Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead), Implantable Cardioverter Defibrillator (ICD), Permanent Defibrillator Electrode (Lead) · First cleared Jan 2016 · 3 device variants grouped

Total Reports

2,376

Reports (30d)

18

Active Signals

2

Open Recalls

82

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

RV Lead Triggered Lead Integrity Alert

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

7

reports

2

RV Lead Exhibited High Defibrillation Impedance

lead explanted, lead remains, impedance, lead exhibited, defibrillation

5

reports

3

RV Lead Oversensing Causing Pacing Inhibition

patient complications, alert lia, result event, lia, integrity

4

reports

4

RV Lead Exhibited High Thresholds and Replaced

lead explanted, lead exhibited, thresholds, exhibited high, explanted replaced

3

reports

5

RV Lead Exhibited High Thresholds

lead remains, lead exhibited, thresholds, exhibited high, use right

3

reports

6

RV Lead Exhibited Undersensing During AT/AF

atrial, undersensing, lead exhibited, atrial fibrillation, right atrial

3

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 reportinghighIncreasing trendcritical

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

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.