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Sprint Quattro Secure S 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

39,133

Reports (30d)

556

Active Signals

1

Open Recalls

82

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Impedance / Ventricular Lead / Pacing Impedance

lead remains, pacing impedance, impedance, high, ventricular lead

199

reports

2

Integrity / Lia / Alert Lia

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

162

reports

3

CRT System Explanted for Infection

crt, infection, therapy, patient complications, result event

69

reports

4

Twos / Oversensing Twos / Wave Oversensing

oversensing twos, wave oversensing, reprogrammed, lead exhibited, use right

48

reports

5

Ventricular Lead / High / Successfully

sensing, showed, successfully, high, ventricular lead

38

reports

6

Ventricular Lead / Lead Explanted / Explanted Replaced

lead explanted, leads, right atrial, explanted replaced, ventricular lead

38

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 reportingmedium

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

In Vivo Durability of Polyurethane Insulated Implantable Cardioverter Defibrillator (ICD) Leads.

Salih A, et al. · Polymers · 2024

Safety, efficacy, and reliability evaluation of a novel small-diameter defibrillation lead: Global LEADR pivotal trial results

George H. Crossley, et al. · Heart Rhythm · 2024

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.