Login Get Early Access

Back to Cardiac Rhythm Management

Visia AF MRI S VR SureScan Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · Implantable Cardioverter Defibrillator (ICD) · First cleared Nov 2016

Total Reports

228

Reports (30d)

1

Active Signals

1

Open Recalls

82

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Inappropriate ATP for SVT Detected

patient complications, tachycardia, ventricular tachycardia, detected, result event

1

reports

2

Inappropriate Shock for Atrial Event

icd remains, event patient, patient complications, complications, result event

1

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 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.

Keep exploring

Related devices in CRM

CAPSUREFIX Novus

MEDTRONIC, INC. · 44,929 reports

EMBLEM S-ICD

BOSTON SCIENTIFIC CORPORATION · 37,761 reports

Sprint Quattro Secure S MRI SureScan

MEDTRONIC, INC. · 37,430 reports

CapSureFix Novus MRI SureScan

MEDTRONIC, INC. · 28,090 reports

Durata

ABBOTT (ST. JUDE MEDICAL) · 19,969 reports

Quadra Assura MP

ABBOTT (ST. JUDE MEDICAL) · 10,531 reports

Want automated safety signal detection?

Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 1 active signal detected right now.

Get Early Access

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.