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OPTIMIZER Adverse Events: FDA MAUDE Data

Impulse Dynamics (usa) Inc. · Cardiac Contractility Modulation (CCM) · First cleared Mar 2019 · 4 device variants grouped

Total Reports

171

Reports (30d)

5

Active Signals

3

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

Detection

Active safety signals

ChangepointhighVolume spikehighNew problem typehigh

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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 3 active signals detected right now.

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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.