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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

2,456

Reports (30d)

18

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

21

reports

2

RV Lead Integrity Alert Triggered

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

7

reports

3

T-Wave Oversensing in RV Lead

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

2

reports

4

Inappropriate ATP and Shock Delivery

svt, fibrillation, tachycardia, ventricular tachycardia, detected

2

reports

5

RV Lead Explanted for Unknown Reason

lead explanted, post, defibrillation, atrial lead, right atrial

2

reports

6

RV Lead Undersensing Observed

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

2

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

Rice B, et al. · JACC. Case reports · 2025

Thompson AE, et al. · Pacing and clinical electrophysiology : PACE · 2022

Pham TDN, et al. · HeartRhythm case reports · 2019

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.