Heart Failure & Neuromodulation Adverse Event Data

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

Total Reports

468

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)	196	9
BAROSTIM NEODSR	CVRX, INC.	Carotid Sinus Nerve Stimulator (Barostim)	94	5
OPTIMIZERQFV	Impulse Dynamics (usa) Inc.	Cardiac Contractility Modulation (CCM)	88	4
BAROSTIM NEODSR	CVRX, INC.	Carotid Sinus Nerve Stimulator (Barostim)	47	0
OPTIMIZER™QFV	Impulse Dynamics (usa) Inc.	Cardiac Contractility Modulation (CCM)	16	0
BarostimDSR	CVRX, INC.	Carotid Sinus Nerve Stimulator (Barostim)	5	0
Neo LegacyDSR	CVRX, INC.	Carotid Sinus Nerve Stimulator (Barostim)	5	0
BAROSTIM NEODSR	CVRX, INC.	Carotid Sinus Nerve Stimulator (Barostim)	4	0
IMPLANTABLE PULSE GENERATORQFV	IMPULSE DYNAMICS	Cardiac Contractility Modulation (CCM)	3	0
OPTIMIZERQFV	Impulse Dynamics (usa) Inc.	Cardiac Contractility Modulation (CCM)	2	0
OPTIMIZER™QFV	Impulse Dynamics (usa) Inc.	Cardiac Contractility Modulation (CCM)	2	0
OMNI™ IIQFV	Impulse Dynamics (usa) Inc.	Cardiac Contractility Modulation (CCM)	1	0
BAROSTIM NEODSR	UNKNOWN	Carotid Sinus Nerve Stimulator (Barostim)	1	0
OPTIMIZER SMART MINIQFV	CCM / IMPULSE DYNAMICS USA INC	Cardiac Contractility Modulation (CCM)	1	0
CCM DEVICEQFV	IMPULSE DYNAMICS USA INC	Cardiac Contractility Modulation (CCM)	1	0
CVRX IMPLANTABLE PULSE GENERATORDSR	CVRX, INC.	Carotid Sinus Nerve Stimulator (Barostim)	1	0
CHARGER DEVICEQFV	IMPULSE DYNAMICS USA INC	Cardiac Contractility Modulation (CCM)	1	0
GuardioQFV	Impulse Dynamics (usa) Inc.	Cardiac Contractility Modulation (CCM)	0	0
BAROSTIM ProgrammerDSR	CVRX, INC.	Carotid Sinus Nerve Stimulator (Barostim)	0	0
BAROSTIM Lead Repair KitDSR	CVRX, INC.	Carotid Sinus Nerve Stimulator (Barostim)	0	0
NADSR	CVRX, INC.	Carotid Sinus Nerve Stimulator (Barostim)	0	0
VestaQFV	Impulse Dynamics (usa) Inc.	Cardiac Contractility Modulation (CCM)	0	0
INFINITY 7 IMPLANTABLE PULSE GENERATORQFV	ABBOTT (ST. JUDE MEDICAL)	Cardiac Contractility Modulation (CCM)	0	0
VestaQFV	Impulse Dynamics (usa) Inc.	Cardiac Contractility Modulation (CCM)	0	0
IntelioQFV	Impulse Dynamics (usa) Inc.	Cardiac Contractility Modulation (CCM)	0	0

1–25 of 26 devices

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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.