Cardiac Rhythm Management Adverse Event Data

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

Total Reports

498,567

Devices Tracked

200

Reports (30d)

6,131

Active Signals

226

Monthly Report Volume

Event Type Breakdown

Devices in CRM

Device	Manufacturer	Type	Total Reports	Last 30d
CAPSUREFIX® NOVUSDTB	MEDTRONIC, INC.	Permanent Pacemaker Electrode (Lead)	64,316	1705
Sprint Quattro Secure S MRI™ SureScan™LWS	MEDTRONIC, INC.	Implantable Cardioverter Defibrillator (ICD)	38,021	532
CapSureFix Novus MRI™ SureScan®DTB	MEDTRONIC, INC.	Permanent Pacemaker Electrode (Lead)	27,056	35
EMBLEM™ MRI S-ICDLWS	BOSTON SCIENTIFIC CORPORATION	Implantable Cardioverter Defibrillator (ICD)	21,766	299
CapSureFix Novus MRI™ SureScan®DTB	MEDTRONIC, INC.	Permanent Pacemaker Electrode (Lead)	17,867	4
CAPSUREFIX® NOVUSDTB	MEDTRONIC, INC.	Permanent Pacemaker Electrode (Lead)	10,249	1
LINQ II™MXD	MEDTRONIC, INC.	Insertable Cardiac Monitor (ICM/ILR)	9,921	1
QUADRA ASSURA MP™NIK	ABBOTT (ST. JUDE MEDICAL)	CRT-Defibrillator (CRT-D)	9,715	17
Gallant™NIK	ABBOTT (ST. JUDE MEDICAL)	CRT-Defibrillator (CRT-D)	8,998	162
EMBLEM™ S-ICDLWS	BOSTON SCIENTIFIC CORPORATION	Implantable Cardioverter Defibrillator (ICD)	8,273	22
EMBLEM™ S-ICDLWS	BOSTON SCIENTIFIC CORPORATION	Implantable Cardioverter Defibrillator (ICD)	8,013	165
Reveal LINQ™MXD	MEDTRONIC, INC.	Insertable Cardiac Monitor (ICM/ILR)	5,855	0
Durata™NVY	ABBOTT (ST. JUDE MEDICAL)	Permanent Defibrillator Electrode (Lead)	5,849	46
SPRINT QUATTRO SECURE® DXAC/DSPLWS	MEDTRONIC, INC.	Implantable Cardioverter Defibrillator (ICD)	5,618	1
Quartet™NIK	ABBOTT (ST. JUDE MEDICAL)	CRT-Defibrillator (CRT-D)	5,325	43
CAPSUREFIX® NOVUSDTB	MEDTRONIC, INC.	Permanent Pacemaker Electrode (Lead)	5,244	0
PERMANENT PACEMAKER ELECTRODEDTB	MEDTRONIC, INC.	Permanent Pacemaker Electrode (Lead)	4,760	17
SPRINT FIDELISLWS	MEDTRONIC, INC.	Implantable Cardioverter Defibrillator (ICD)	4,681	25
Durata™NVY	ABBOTT (ST. JUDE MEDICAL)	Permanent Defibrillator Electrode (Lead)	4,573	51
Micra™ AVPNJ	MEDTRONIC, INC.	Leadless Pacemaker	4,262	28
RIATA ACTIVE FIXATIONNVY	ABBOTT (ST. JUDE MEDICAL)	Permanent Defibrillator Electrode (Lead)	3,826	0
Capsurefix® NovusNVY	MEDTRONIC, INC.	Permanent Defibrillator Electrode (Lead)	3,801	19
Micra™ VR2PNJ	MEDTRONIC, INC.	Leadless Pacemaker	3,798	59
RELIANCE 4-FRONT™NVY	BOSTON SCIENTIFIC CORPORATION	Permanent Defibrillator Electrode (Lead)	3,740	95
Evera MRI™ XT DR SureScan®LWS	MEDTRONIC, INC.	Implantable Cardioverter Defibrillator (ICD)	3,600	15

1–25 of 200 devices

1 / 8

All CRM device pages (238)

CAPSUREFIX NOVUS EMBLEM S-ICD Sprint Quattro Secure S MRI SureScan Durata Quadra Assura MP LINQ II Gallant CRT-D Quartet RELIANCE 4-FRONT Aveir FINELINE II EZ Sterox ENDOTAK RELIANCE SG Reveal LINQ SPRINT QUATTRO SECURE DXAC/DSP ENDOTAK RELIANCE G Optisure Evera MRI XT DR SureScan Sprint Quattro Secure Plexa ProMRI PERMANENT PACEMAKER ELECTRODE Unify Assura SPRINT FIDELIS Gallant ICD Micra AV Claria MRI Quad CRT-D SureScan Isoflex CAPSURE SP Novus RIATA ACTIVE FIXATION Micra VR2 Quadra Assura FORTIFY ASSURA VR ICD, US CapSure Sense Micra AV2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON CRT)CapSureFix Novus MRI SureScan Cobalt XT DR MRI SureScan Cobalt XT HF Quad CRT-D MRI SureScan FLEXTEND ELLIPSE DR ICD, US Visia AF MRI VR SureScan Sprint Quattro Secure MRI SureScan VIGILANT X4 CRT-D PERMANENT DEFIBRILLATOR ELECTRODES Evera XT DR VALITUDE X4 CRT-P MOMENTUM CRT-D CAPSURE Z NOVUS Micra RESONATE X4 CRT-D Unidentified MEDTRONIC, INC.FINELINE II Sterox DYNAGEN EL ICD DR VISIONIST X4 CRT-P Epsila EV MRI SureScan Capsure EPI Amplia MRI Quad CRT-D SureScan RESONATE EL ICD DR VIGILANT EL ICD DR Quadra Allure MP Percepta Quad CRT-P MRI SureScan Viva XT CRT-D Claria MRI CRT-D SureScan Neutrino DYNAGEN X4 CRT-D INOGEN EL ICD DR ENDOTAK RELIANCE Sprint Quattro INOGEN X4 CRT-D DYNAGEN EL ICD VR INOGEN EL ICD VR Cobalt HF Quad CRT-D MRI SureScan AUTOGEN MOMENTUM EL ICD DR ENDOTAK RELIANCE S EMBLEM S ICD EASYTRAK 2 IS-1 Linox Smart S DX 65/15 Evera XT VR Cobalt DR MRI SureScan Cobalt XT HF CRT-D MRI SureScan Merlin Linox Smart S 65 Protego VIGILANT EL ICD VR DYNAGEN CRT-D Evera MRI S DR SureScan RESONATE EL ICD VR Cobalt XT VR MRI SureScan Viva Quad XT CRT-D TENDRIL MRI Sprint Quattro Secure S DXAC/DSP Myopore Sutureless Myocardial Pacing Lead INVIVE BioMonitor III RESONATE HF CRT-D Linox Smart SD 65/18 Aurora EV-ICD MRI SureScan VISIONIST CRT-P Acticor 7 VR-T DX DF4 ProMRI MOMENTUM X4 CRT-D SQ RX PULSE GENERATOR VALITUDE CRT-P Sprint Quattro Secure S Inventra 7 VR-T DX DF-1 ProMRI ASSURITY MRI LUX-Dx Insertable Cardiac Monitor OmniaSecure MRI SureScan ENDURITY PACEMAKER, DR, MRI RESTRICTED Amplia MRI CRT-D SureScan RESONATE HF ICD DR Capsurefix DXAC/DSP DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO LUX-Dx II+Linox Smart SD 65/16 FORTIFY VR, U1.6 SJ4 ID LEAD CapSureZ Novus Percepta CRT-P MRI SureScan TRANSVENOUS LEAD Linox Smart S DX 65/17 Cobalt HF CRT-D MRI SureScan Evera S VR Compia MRI CRT-D SureScan Evera S DR Cobalt VR MRI SureScan Iperia 7 VR-T DX DF-1 ProMRI BioMonitor IIIm Allure Protego S 65 RIATA ST OPTIM LEAD MOMENTUM EL ICD VR INOGEN CRT-D Entrant CRYSTALLINE ACTFIX Intica 7 VR-T DX DF-1 ProMRI CapsureSP Novus ACUITY Steerable Solara Quad CRT-P MRI SureScan RA LEAD RIATA ST PASSIVE FIXATION Protecta XT VR Allure Quadra DYNAGEN MINI ICD DR PERCIVA ICD DR Unify Quadra Rivacor 7 HF-T QP DF4 IS4 ProMRI RV LEAD Visia AF MRI S VR SureScan Viva Quad S CRT-D Itrevia 5 VR-T Linox Smart SD 60/16 Serena Quad CRT-P MRI SureScan TRANSVENE SVC LEAD Pamira S DX 65/15 Crome HF CRT-D MRI SureScan EASYTRAK 2 VITATRON E SERIES S INTUA CHARISMA CAPSURE VDD 2 LEAD PLATINIUM Lumax 740 VR-T Victory UNIFY SUBCUTANEOUS, UNIPOLAR LEAD Verity Plexa ProMRI S 60 RV LEAD Iperia 7 VR-T PERCIVA ICD VR Acticor 7 HF-T QP DF4 IS4 ProMRI Ilivia 7 VR-T DF4 ProMRI NEUTRINO NXT HF Ilesto 7 VR-T DX DF-1 US Crome DR MRI SureScan Evera MRI XT VR SureScan The Q-TRAK Subcutaneous Electrode Viva S CRT-D Sprint Quattro MRI SureScan Lumax 740 VR-T DX DYNAGEN MINI ICD VR CAPSUREFIX LEAD Visia AF VR Protecta XT DR Identity Protego DF-1 Pamira S 65 Iforia 5 VR-T ALIZEA Maximo II VR RESONATE HF ICD VR CARELINK SYSTEM CAPSUREFIX Intica Neo 5 VR-T DF-1 ProMRI Primo MRI DR SureScan INOGEN MINI ICD VR Compia MRI Quad CRT-D SureScan Crome VR MRI SureScan IMPLANTABLE PACEMAKER PULSE GENERATOR Linox Smart S 60 Evera MRI S VR SureScan Iforia 7 VR-T DX DF-1 US ELLIPSE VR Protego SD 65/18 EXCELLENCE+Crome HF Quad CRT-D MRI SureScan BioMonitor 2-AF FLEXION PERMANENT PACING LEAD CAPSURE VDD-2 Edora 8 HF-T QP VOLTA SQ-RX PULSE GENERATOR INOGEN MINI ICD DR LUX-Dx Protecta DR Tendril Ilivia 7 HF-T QP DF4 IS4 ProMRI VIRTUOSO VR Ilivia 7 VR-T DF-1 ProMRI BRAVA CRT D TARGET TIP Solara CRT-P MRI SureScan ABBOTT ICD Primo MRI VR SureScan Iforia 5 VR-T DX DF-1 Protego S 60 Protecta XT CRT-D LATITUDE COMMUNICATOR ATRIAL LEAD Linox Smart TD 65/16 RV LEAD EGIDA CRT D ANTHEM Serena CRT-P MRI SureScan Intica Neo 5 VR-T DX DF-1 ProMRI BioMonitor IV LEAD ABBOTT PACEMAKER

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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.