Cardiac Rhythm Management Adverse Event Data

Pacemakers, ICDs, CRT devices, leads, and insertable cardiac monitors — adverse event trends and safety signals.

Total Reports

451,306

Devices Tracked

200

Reports (30d)

6,771

Active Signals

599

Monthly Report Volume

Event Type Breakdown

Devices in CRM

Device	Manufacturer	Type	Total Reports	Last 30d
Sprint Quattro Secure S MRI™ SureScan™LWS	MEDTRONIC, INC.	Implantable Cardioverter Defibrillator (ICD)	34,711	632
CAPSUREFIX® NOVUSDTB	MEDTRONIC, INC.	Permanent Pacemaker Electrode (Lead)	28,335	39
CapSureFix Novus MRI™ SureScan®NVY	MEDTRONIC, INC.	Permanent Defibrillator Electrode (Lead)	26,521	504
CapSureFix Novus MRI™ SureScan®DTB	MEDTRONIC, INC.	Permanent Pacemaker Electrode (Lead)	26,119	349
EMBLEM™ MRI S-ICDLWS	BOSTON SCIENTIFIC CORPORATION	Implantable Cardioverter Defibrillator (ICD)	19,959	329
CapSureFix Novus MRI™ SureScan®DTB	MEDTRONIC, INC.	Permanent Pacemaker Electrode (Lead)	16,521	242
QUADRA ASSURA MP™NIK	ABBOTT (ST. JUDE MEDICAL)	CRT-Defibrillator (CRT-D)	9,536	23
CAPSUREFIX® NOVUSDTB	MEDTRONIC, INC.	Permanent Pacemaker Electrode (Lead)	9,491	154
LINQ II™MXD	MEDTRONIC, INC.	Insertable Cardiac Monitor (ICM/ILR)	8,779	210
EMBLEM™ S-ICDLWS	BOSTON SCIENTIFIC CORPORATION	Implantable Cardioverter Defibrillator (ICD)	8,278	27
Gallant™NIK	ABBOTT (ST. JUDE MEDICAL)	CRT-Defibrillator (CRT-D)	7,956	171
EMBLEM™ S-ICDLWS	BOSTON SCIENTIFIC CORPORATION	Implantable Cardioverter Defibrillator (ICD)	6,905	179
Durata™NVY	ABBOTT (ST. JUDE MEDICAL)	Permanent Defibrillator Electrode (Lead)	5,459	40
SPRINT QUATTRO SECURE® DXAC/DSPLWS	MEDTRONIC, INC.	Implantable Cardioverter Defibrillator (ICD)	5,373	64
Quartet™NIK	ABBOTT (ST. JUDE MEDICAL)	CRT-Defibrillator (CRT-D)	4,965	52
CAPSUREFIX® NOVUSDTB	MEDTRONIC, INC.	Permanent Pacemaker Electrode (Lead)	4,893	75
Sprint Quattro Secure®NVY	MEDTRONIC, INC.	Permanent Defibrillator Electrode (Lead)	4,632	66
PERMANENT PACEMAKER ELECTRODEDTB	MEDTRONIC, INC.	Permanent Pacemaker Electrode (Lead)	4,567	1
SPRINT FIDELISLWS	MEDTRONIC, INC.	Implantable Cardioverter Defibrillator (ICD)	4,515	43
Durata™NVY	ABBOTT (ST. JUDE MEDICAL)	Permanent Defibrillator Electrode (Lead)	4,245	48
Micra™ AVPNJ	MEDTRONIC, INC.	Leadless Pacemaker	4,093	25
Capsurefix® NovusNVY	MEDTRONIC, INC.	Permanent Defibrillator Electrode (Lead)	3,584	35
Evera MRI™ XT DR SureScan®LWS	MEDTRONIC, INC.	Implantable Cardioverter Defibrillator (ICD)	3,411	43
Micra™ VR2PNJ	MEDTRONIC, INC.	Leadless Pacemaker	3,399	74
CAPSURE SP NOVUS®DTB	MEDTRONIC, INC.	Permanent Pacemaker Electrode (Lead)	3,363	3

1–25 of 200 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.