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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

38,006

Reports (30d)

32

Active Signals

0

Open Recalls

82

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Rising Defibrillation Impedance in RV Lead

lead remains, pacing impedance, impedance, lead exhibited, use right

130

reports

2

RV Lead Integrity Alert Triggered

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

114

reports

3

T-Wave Oversensing in RV Lead

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

89

reports

4

RV Lead Undersensing Observed

episode, lead remains, undersensing, lead exhibited, use right

38

reports

5

CRT Device Explanted for Infection

crt, infection, patient complications, patient experienced, result event

29

reports

6

Pocket Infection Leading to Explant

implantable cardioverter, infection, pocket, cardioverter defibrillator, defibrillator icd

19

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

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

Anmar Salih, et al. · Polymers · 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.