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Viva Quad XT CRT-D Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · CRT-Defibrillator (CRT-D) · First cleared Jul 2021

Total Reports

582

Reports (30d)

0

Active Signals

0

Open Recalls

78

Monthly Report Volume

Event Type Breakdown

Regulatory

FDA recalls for this device

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.

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

Hasebe H, et al. · Indian pacing and electrophysiology journal · 2016

Docekal JW, et al. · HeartRhythm case reports · 2016

Magnetic field interactions of smartwatches and portable electronic devices with CIEDs – Did we open a Pandora’s box?

Patrick Badertscher, et al. · IJC Heart & Vasculature · 2022

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.