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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

36,335

Reports (30d)

525

Active Signals

4

Open Recalls

82

Monthly Report Volume

No timeline data available.

Event Type Breakdown

No event type data available.

What the reports describe · Claripulse analysis

Most commonly reported problems

1

RV Lead Triggered Lead Integrity Alert

integrity alert, lead integrity, ventricular tachycardia, alert lia, lia

145

reports

2

CRT-D Explanted Due to Infection

cardiac resynchronization, crt, infection, therapy defibrillator, resynchronization therapy

92

reports

3

RV Lead Exhibited T-Wave Oversensing

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

57

reports

4

RV Lead Exhibited High Pacing Impedance

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

46

reports

5

RV Lead Exhibited High Pacing Impedance and Replaced

suspected, lead explanted, pacing impedance, lead exhibited, fracture

45

reports

6

RV Lead Exhibited Undersensing and Remains in Use

lead remains, undersensing, lead exhibited, use right, stored

44

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 trendcriticalDisproportionate reportingmediumDisproportionate reportinghigh

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. · 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.