Ilesto 7 VR-T DX DF-1 US Adverse Events: FDA MAUDE Data

BIOTRONIK SE & Co. KG · Implantable Cardioverter Defibrillator (ICD) · First cleared May 2024

Total Reports

222

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

Detection

Active safety signals

Disproportionate reportinghigh

Evidence

Related research

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.

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How a safety signal is detected

What the "Active Signals" count above means and the methods that separate a real signal from noise.

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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.