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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

2,457

Reports (30d)

1

Active Signals

0

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

8

reports

2

Integrity / Lia / Alert Lia

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

7

reports

3

RV Lead Fracture Causing Inappropriate Shocks

lead explanted, patient complications, explanted replaced, ventricular lead, result event

2

reports

4

T-Wave Oversensing with Lead in Use

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

2

reports

5

Thresholds / Use Right / Exhibited High

lead exhibited, thresholds, exhibited high, use right, ventricular lead

2

reports

6

RV Lead Exhibited Undersensing

lead remains, undersensing, lead exhibited, use right, ventricular lead

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

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.