Heart Failure & Neuromodulation Adverse Event Data

Cardiac contractility modulation (CCM) and carotid sinus nerve stimulation (Barostim) adverse events.

Total Reports

595

Devices Tracked

Reports (30d)

Active Signals

Monthly Report Volume

Event Type Breakdown

Devices in HF/Neuromod

Device	Manufacturer	Type	Total Reports	Last 30d
Barostim NEO2DSR	CVRX, INC.	Carotid Sinus Nerve Stimulator (Barostim)	235	9
OPTIMIZERQFV	Impulse Dynamics (usa) Inc.	Cardiac Contractility Modulation (CCM)	124	23
BAROSTIM NEODSR	CVRX, INC.	Carotid Sinus Nerve Stimulator (Barostim)	120	3
BAROSTIM NEODSR	CVRX, INC.	Carotid Sinus Nerve Stimulator (Barostim)	48	0
OPTIMIZER™QFV	Impulse Dynamics (usa) Inc.	Cardiac Contractility Modulation (CCM)	19	1
OPTIMIZER™QFV	Impulse Dynamics (usa) Inc.	Cardiac Contractility Modulation (CCM)	19	15
BarostimDSR	CVRX, INC.	Carotid Sinus Nerve Stimulator (Barostim)	10	0
Neo LegacyDSR	CVRX, INC.	Carotid Sinus Nerve Stimulator (Barostim)	5	0
OPTIMIZERQFV	Impulse Dynamics (usa) Inc.	Cardiac Contractility Modulation (CCM)	4	1
IMPLANTABLE PULSE GENERATORQFV	IMPULSE DYNAMICS	Cardiac Contractility Modulation (CCM)	3	0
CHARGER DEVICEQFV	IMPULSE DYNAMICS USA INC	Cardiac Contractility Modulation (CCM)	1	0
OPTIMIZER SMART MINIQFV	CCM / IMPULSE DYNAMICS USA INC	Cardiac Contractility Modulation (CCM)	1	0
INFINITY 7 IMPLANTABLE PULSE GENERATORQFV	ABBOTT (ST. JUDE MEDICAL)	Cardiac Contractility Modulation (CCM)	1	0
BAROSTIM NEODSR	UNKNOWN	Carotid Sinus Nerve Stimulator (Barostim)	1	0
CVRX IMPLANTABLE PULSE GENERATORDSR	CVRX, INC.	Carotid Sinus Nerve Stimulator (Barostim)	1	0
OMNI™ IIQFV	Impulse Dynamics (usa) Inc.	Cardiac Contractility Modulation (CCM)	1	0
CCM DEVICEQFV	IMPULSE DYNAMICS USA INC	Cardiac Contractility Modulation (CCM)	1	0
CARDIAC CONTRACTILITY MODULATION DEVICEQFV	IMPULSE DYNAMICS USA INC	Cardiac Contractility Modulation (CCM)	1	0
VestaQFV	Impulse Dynamics (usa) Inc.	Cardiac Contractility Modulation (CCM)	0	0
BAROSTIM Lead Repair KitDSR	CVRX, INC.	Carotid Sinus Nerve Stimulator (Barostim)	0	0
BAROSTIM ProgrammerDSR	CVRX, INC.	Carotid Sinus Nerve Stimulator (Barostim)	0	0
NADSR	CVRX, INC.	Carotid Sinus Nerve Stimulator (Barostim)	0	0
BAROSTIM NEODSR	CVRX, INC.	Carotid Sinus Nerve Stimulator (Barostim)	0	0
IntelioQFV	Impulse Dynamics (usa) Inc.	Cardiac Contractility Modulation (CCM)	0	0
GuardioQFV	Impulse Dynamics (usa) Inc.	Cardiac Contractility Modulation (CCM)	0	0

1–25 of 27 devices

1 / 2

All HF/Neuromod device pages (3)

Barostim NEO2 BAROSTIM NEO OPTIMIZER

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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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Post-market surveillance: a practical guide

Where MAUDE fits in the wider regulatory picture and the data sources teams rely on.

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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.