Cardiac Rhythm Management Adverse Event Data

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

Total Reports

476,560

Devices Tracked

200

Reports (30d)

6,368

Active Signals

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)	36,844	516
CAPSUREFIX® NOVUSDTB	MEDTRONIC, INC.	Permanent Pacemaker Electrode (Lead)	29,771	1
CapSureFix Novus MRI™ SureScan®NVY	MEDTRONIC, INC.	Permanent Defibrillator Electrode (Lead)	28,620	530
CapSureFix Novus MRI™ SureScan®DTB	MEDTRONIC, INC.	Permanent Pacemaker Electrode (Lead)	27,595	335
EMBLEM™ MRI S-ICDLWS	BOSTON SCIENTIFIC CORPORATION	Implantable Cardioverter Defibrillator (ICD)	20,991	240
CapSureFix Novus MRI™ SureScan®DTB	MEDTRONIC, INC.	Permanent Pacemaker Electrode (Lead)	17,650	272
CAPSUREFIX® NOVUSDTB	MEDTRONIC, INC.	Permanent Pacemaker Electrode (Lead)	10,121	172
LINQ II™MXD	MEDTRONIC, INC.	Insertable Cardiac Monitor (ICM/ILR)	9,759	244
QUADRA ASSURA MP™NIK	ABBOTT (ST. JUDE MEDICAL)	CRT-Defibrillator (CRT-D)	9,655	20
Gallant™NIK	ABBOTT (ST. JUDE MEDICAL)	CRT-Defibrillator (CRT-D)	8,577	159
EMBLEM™ S-ICDLWS	BOSTON SCIENTIFIC CORPORATION	Implantable Cardioverter Defibrillator (ICD)	8,410	23
EMBLEM™ S-ICDLWS	BOSTON SCIENTIFIC CORPORATION	Implantable Cardioverter Defibrillator (ICD)	7,522	161
Durata™NVY	ABBOTT (ST. JUDE MEDICAL)	Permanent Defibrillator Electrode (Lead)	5,715	56
SPRINT QUATTRO SECURE® DXAC/DSPLWS	MEDTRONIC, INC.	Implantable Cardioverter Defibrillator (ICD)	5,580	61
Micra™PNJ	MEDTRONIC, INC.	Leadless Pacemaker	5,291	2
Quartet™NIK	ABBOTT (ST. JUDE MEDICAL)	CRT-Defibrillator (CRT-D)	5,193	66
CAPSUREFIX® NOVUSDTB	MEDTRONIC, INC.	Permanent Pacemaker Electrode (Lead)	5,189	68
Sprint Quattro Secure®NVY	MEDTRONIC, INC.	Permanent Defibrillator Electrode (Lead)	4,853	60
PERMANENT PACEMAKER ELECTRODEDTB	MEDTRONIC, INC.	Permanent Pacemaker Electrode (Lead)	4,684	11
SPRINT FIDELISLWS	MEDTRONIC, INC.	Implantable Cardioverter Defibrillator (ICD)	4,615	38
Durata™NVY	ABBOTT (ST. JUDE MEDICAL)	Permanent Defibrillator Electrode (Lead)	4,435	48
Micra™ AVPNJ	MEDTRONIC, INC.	Leadless Pacemaker	3,996	23
Capsurefix® NovusNVY	MEDTRONIC, INC.	Permanent Defibrillator Electrode (Lead)	3,729	36
Evera MRI™ XT DR SureScan®LWS	MEDTRONIC, INC.	Implantable Cardioverter Defibrillator (ICD)	3,540	57
CAPSURE SP NOVUS®DTB	MEDTRONIC, INC.	Permanent Pacemaker Electrode (Lead)	3,526	4

1–25 of 200 devices

1 / 8

All CRM device pages (227)

CAPSUREFIX Novus EMBLEM S-ICD Sprint Quattro Secure S MRI SureScan CapSureFix Novus MRI SureScan Durata Quadra Assura MP LINQ II Gallant CRT-D Quartet FINELINE II EZ Sterox SPRINT QUATTRO SECURE DXAC/DSP Aveir Micra Plexa ProMRI Optisure Evera MRI XT DR SureScan Sprint Quattro Secure Unify Assura PERMANENT PACEMAKER ELECTRODE SPRINT FIDELIS Gallant ICD Claria MRI Quad CRT-D SureScan Isoflex Micra AV CAPSURE SP Novus RELIANCE 4-FRONT ENDOTAK RELIANCE SG CapSure Sense FORTIFY ASSURA VR ICD, US RIATA ACTIVE FIXATION Quadra Assura ENDOTAK RELIANCE G Capsure EPI Micra AV2 FLEXTEND Sprint Quattro Secure MRI SureScan PERMANENT DEFIBRILLATOR ELECTRODES VIGILANT X4 CRT-D Cobalt XT HF Quad CRT-D MRI SureScan Cobalt XT DR MRI SureScan RESONATE X4 CRT-D VALITUDE X4 CRT-P Capsurefix DXAC/DSP Sprint Quattro Secure S RESONATE EL ICD DR Visia AF MRI VR SureScan VIGILANT EL ICD DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON CRT)VISIONIST X4 CRT-P ELLIPSE DR ICD, US Epsila EV MRI SureScan Percepta Quad CRT-P MRI SureScan Unidentified MEDTRONIC, INC.Neutrino Evera XT DR Quadra Allure MP Protego S 65 Sprint Quattro DYNAGEN EL ICD DR AUTOGEN RIATA ST PASSIVE FIXATION MOMENTUM EL ICD DR Linox Smart S DX 65/15 ELLIPSE VR MOMENTUM CRT-D INOGEN X4 CRT-D Viva XT CRT-D Cobalt HF Quad CRT-D MRI SureScan DYNAGEN X4 CRT-D INOGEN EL ICD DR Linox Smart S 65 Amplia MRI Quad CRT-D SureScan INOGEN EL ICD VR VIGILANT EL ICD VR FINELINE II Sterox Micra VR2 RESONATE EL ICD VR TENDRIL MRI MEDTRONIC LEAD Claria MRI CRT-D SureScan DYNAGEN EL ICD VR ENDOTAK RELIANCE S INVIVE Cobalt DR MRI SureScan BioMonitor III Cobalt XT VR MRI SureScan Percepta CRT-P MRI SureScan Linox Smart SD 65/18 Merlin Evera XT VR MOMENTUM X4 CRT-D Evera MRI S DR SureScan Acticor 7 VR-T DX DF4 ProMRI Aurora EV-ICD MRI SureScan EASYTRAK 2 IS-1 Viva Quad XT CRT-D ASSURITY MRI Inventra 7 VR-T DX DF-1 ProMRI Cobalt XT HF CRT-D MRI SureScan LUX-Dx Insertable Cardiac Monitor VALITUDE CRT-P VISIONIST CRT-P ENDURITY PACEMAKER, DR, MRI RESTRICTED RESONATE HF CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO Linox Smart SD 65/16 ENDOTAK RELIANCE CapSureZ Novus Sprint Quattro Secure S DXAC/DSP RESONATE HF ICD DR LEAD Linox Smart S DX 65/17 EMBLEM S ICD SQ RX PULSE GENERATOR Compia MRI CRT-D SureScan Iperia 7 VR-T DX DF-1 ProMRI FORTIFY VR, U1.6 SJ4 ID BioMonitor IIIm RIATA ST OPTIM LEAD DYNAGEN CRT-D Allure LUX-Dx II+MOMENTUM EL ICD VR CRYSTALLINE ACTFIX CapsureSP Novus Intica 7 VR-T DX DF-1 ProMRI Myopore Sutureless Myocardial Pacing Lead TRANSVENOUS LEAD Linox Smart SD 60/16 Entrant Cobalt VR MRI SureScan RA LEAD Allure Quadra SQ-RX PULSE GENERATOR Rivacor 7 HF-T QP DF4 IS4 ProMRI INOGEN CRT-D RV LEAD Iforia 5 VR-T Itrevia 5 VR-T Evera S DR Amplia MRI CRT-D SureScan Unify Quadra PERCIVA ICD DR Visia AF VR DYNAGEN MINI ICD DR RV LEAD Protecta XT VR PLATINIUM Pamira S DX 65/15 Evera S VR Lumax 740 VR-T Victory INTUA Verity Viva Quad S CRT-D CHARISMA Visia AF MRI S VR SureScan Iperia 7 VR-T Solara Quad CRT-P MRI SureScan ACUITY Steerable Ilesto 7 VR-T DX DF-1 US Ilivia 7 VR-T DF4 ProMRI Evera MRI XT VR SureScan Protecta DR Protego SD 65/18 Acticor 7 HF-T QP DF4 IS4 ProMRI Solara CRT-P MRI SureScan The Q-TRAK Subcutaneous Electrode OmniaSecure MRI SureScan Cobalt HF CRT-D MRI SureScan Epsila EV Serena Quad CRT-P MRI SureScan CAPSUREFIX LEAD ABBOTT ICD Sprint Quattro MRI SureScan Lumax 740 VR-T DX Protecta XT DR Serena CRT-P MRI SureScan PERCIVA ICD VR Maximo II VR CARELINK SYSTEM RIGHT VENTRICULAR (RV) LEAD VITATRON E SERIES S ALIZEA CAPSUREFIX Crome DR MRI SureScan SUBCUTANEOUS, UNIPOLAR LEAD Intica Neo 5 VR-T DF-1 ProMRI FORTIFY DR, U1.6 DF1 ID Compia MRI Quad CRT-D SureScan Viva S CRT-D DYNAGEN MINI ICD VR Pamira S 65 Evera MRI S VR SureScan LATITUDE COMMUNICATOR Iforia 7 VR-T DX DF-1 US EASYTRAK 2 RESONATE HF ICD VR BioMonitor 2-AF EXCELLENCE+Edora 8 HF-T QP Crome VR MRI SureScan Tendril Protego DF-1 Ilivia 7 HF-T QP DF4 IS4 ProMRI VOLTA UNIFY LUX-Dx TARGET TIP BRAVA CRT D Protecta XT CRT-D Ilivia 7 VR-T DF-1 ProMRI Crome HF Quad CRT-D MRI SureScan NEUTRINO NXT HF Identity Protego S 60 TRANSVENE SVC LEAD EGIDA CRT D Iforia 7 VR-T Primo MRI DR SureScan Linox Smart TD 65/16 FLEXION PERMANENT PACING LEAD Linox Smart S 60 INOGEN MINI ICD VR ATRIAL LEAD LEAD Intica Neo 5 VR-T DX DF-1 ProMRI

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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.