IntellaMap Orion Adverse Events: FDA MAUDE Data

BOSTON SCIENTIFIC CORPORATION · Catheter, Electrode Recording (EP Diagnostic) · First cleared Oct 2019

Total Reports

418

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

Detection

Active safety signals

Disproportionate reportinghigh

Evidence

Related research

The use of a high-resolution mapping system may facilitate standard clinical practice in VE and VT ablation.

Sultan A, et al. · 2019

Ultra-high-resolution assessment of lesion extension after cryoballoon ablation for pulmonary vein isolation

Francesco Raffaele Spera, et al. · Frontiers in Cardiovascular Medicine · 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.

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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.