Cardiac Rhythm Management Adverse Event Data
Pacemakers, ICDs, CRT devices, leads, and insertable cardiac monitors — adverse event trends and safety signals.
Total Reports
487,827
Devices Tracked
200
Reports (30d)
4,856
Active Signals
551
Monthly Report Volume
Event Type Breakdown
Devices in CRM
| Device | Total Reports | Last 30d |
|---|---|---|
| 37,445 | 1 | |
CAPSUREFIX® NOVUSDTB | 30,651 | 0 |
| 29,411 | 354 | |
| 28,074 | 151 | |
| 21,468 | 177 | |
| 17,970 | 100 | |
CAPSUREFIX® NOVUSDTB | 11,241 | 985 |
LINQ II™MXD | 10,014 | 60 |
| 9,697 | 16 | |
Gallant™NIK | 8,843 | 131 |
| 8,473 | 24 | |
| 7,842 | 133 | |
Durata™NVY | 5,804 | 42 |
| 5,617 | 0 | |
Micra™PNJ | 5,347 | 3 |
Quartet™NIK | 5,283 | 36 |
CAPSUREFIX® NOVUSDTB | 5,252 | 7 |
| 4,898 | 6 | |
| 4,688 | 0 | |
| 4,662 | 23 | |
Durata™NVY | 4,524 | 42 |
Micra™ AVPNJ | 4,034 | 24 |
Capsurefix® NovusNVY | 3,783 | 26 |
| 3,645 | 60 | |
| 3,597 | 24 |
1–25 of 200 devices
1 / 8
All CRM device pages (231)
CAPSUREFIX NovusEMBLEM S-ICDSprint Quattro Secure S MRI SureScanCapSureFix Novus MRI SureScanDurataQuadra Assura MPLINQ IIGallant CRT-DQuartetAveirFINELINE II EZ SteroxSPRINT QUATTRO SECURE DXAC/DSPMicraPlexa ProMRIOptisureEvera MRI XT DR SureScanSprint Quattro SecureUnify AssuraPERMANENT PACEMAKER ELECTRODESPRINT FIDELISGallant ICDClaria MRI Quad CRT-D SureScanIsoflexMicra AVCAPSURE SP NovusRELIANCE 4-FRONTENDOTAK RELIANCE SGCapSure SenseFORTIFY ASSURA VR ICD, USRIATA ACTIVE FIXATIONCapsure EPIQuadra AssuraENDOTAK RELIANCE GMicra AV2FLEXTENDSprint Quattro Secure MRI SureScanVIGILANT X4 CRT-DPERMANENT DEFIBRILLATOR ELECTRODESCobalt XT HF Quad CRT-D MRI SureScanCobalt XT DR MRI SureScanVALITUDE X4 CRT-PRESONATE X4 CRT-DCapsurefix DXAC/DSPSprint Quattro Secure SVISIONIST X4 CRT-PRESONATE EL ICD DRVIGILANT EL ICD DRVisia AF MRI VR SureScanSprint QuattroIMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON CRT)MEDTRONIC LEADEpsila EV MRI SureScanELLIPSE DR ICD, USPercepta Quad CRT-P MRI SureScanNeutrinoEvera XT DRQuadra Allure MPProtego S 65DYNAGEN EL ICD DRAUTOGENRIATA ST PASSIVE FIXATIONMOMENTUM EL ICD DRLinox Smart S DX 65/15MOMENTUM CRT-DINOGEN X4 CRT-DELLIPSE VRCobalt HF Quad CRT-D MRI SureScanDYNAGEN X4 CRT-DINOGEN EL ICD DRViva XT CRT-DLinox Smart S 65Amplia MRI Quad CRT-D SureScanVIGILANT EL ICD VRINOGEN EL ICD VRMicra VR2RESONATE EL ICD VRFINELINE II SteroxClaria MRI CRT-D SureScanTENDRIL MRICobalt DR MRI SureScanDYNAGEN EL ICD VRENDOTAK RELIANCE SINVIVECobalt XT VR MRI SureScanBioMonitor IIIPercepta CRT-P MRI SureScanLinox Smart SD 65/18MerlinAurora EV-ICD MRI SureScanEvera XT VRUnidentified MEDTRONIC, INC.MOMENTUM X4 CRT-DActicor 7 VR-T DX DF4 ProMRIEvera MRI S DR SureScanEASYTRAK 2 IS-1Cobalt XT HF CRT-D MRI SureScanRESONATE HF CRT-DVALITUDE CRT-PVISIONIST CRT-PViva Quad XT CRT-DASSURITY MRIInventra 7 VR-T DX DF-1 ProMRILUX-Dx Insertable Cardiac MonitorENDURITY PACEMAKER, DR, MRI RESTRICTEDRESONATE HF ICD DRENDOTAK RELIANCEDEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIOLinox Smart SD 65/16CapSureZ NovusSprint Quattro Secure S DXAC/DSPEMBLEM S ICDLinox Smart S DX 65/17LEADSQ RX PULSE GENERATORCompia MRI CRT-D SureScanIperia 7 VR-T DX DF-1 ProMRIFORTIFY VR, U1.6 SJ4 IDBioMonitor IIImLUX-Dx II+AllureDYNAGEN CRT-DMOMENTUM EL ICD VRCRYSTALLINE ACTFIXIntica 7 VR-T DX DF-1 ProMRIMyopore Sutureless Myocardial Pacing LeadCapsureSP NovusTRANSVENOUS LEADEntrantLinox Smart SD 60/16Cobalt VR MRI SureScanRA LEADRivacor 7 HF-T QP DF4 IS4 ProMRIAllure QuadraSQ-RX PULSE GENERATORRIATA ST OPTIM LEADINOGEN CRT-DRV LEADRV LEADOmniaSecure MRI SureScanIforia 5 VR-TItrevia 5 VR-TEvera S DRVisia AF VRPERCIVA ICD DRAmplia MRI CRT-D SureScanUnify QuadraUnidentified ABBOTT (ST. JUDE MEDICAL)DYNAGEN MINI ICD DRPamira S DX 65/15Cobalt HF CRT-D MRI SureScanProtecta XT VRPLATINIUMLumax 740 VR-TEvera S VRCHARISMASolara Quad CRT-P MRI SureScanVictoryINTUAEpsila EVVerityVisia AF MRI S VR SureScanViva Quad S CRT-DACUITY SteerableIperia 7 VR-TProtego SD 65/18Ilivia 7 VR-T DF4 ProMRIIlesto 7 VR-T DX DF-1 USEvera MRI XT VR SureScanActicor 7 HF-T QP DF4 IS4 ProMRIProtecta DRThe Q-TRAK Subcutaneous ElectrodeSolara CRT-P MRI SureScanABBOTT ICDSerena Quad CRT-P MRI SureScanSprint Quattro MRI SureScanLumax 740 VR-T DXCAPSUREFIX LEADPERCIVA ICD VRSerena CRT-P MRI SureScanProtecta XT DRALIZEACrome DR MRI SureScanMaximo II VRPamira S 65Reveal LINQSUBCUTANEOUS, UNIPOLAR LEADCARELINK SYSTEMRIGHT VENTRICULAR (RV) LEADVITATRON E SERIES SCAPSUREFIXIntica Neo 5 VR-T DF-1 ProMRICompia MRI Quad CRT-D SureScanFORTIFY DR, U1.6 DF1 IDRESONATE HF ICD VRDYNAGEN MINI ICD VRViva S CRT-DEvera MRI S VR SureScanLATITUDE COMMUNICATORIforia 7 VR-T DX DF-1 USProtecta XT CRT-DEASYTRAK 2NEUTRINO NXT HFBioMonitor 2-AFEXCELLENCE+Crome VR MRI SureScanEdora 8 HF-T QPProtego DF-1TendrilIlivia 7 HF-T QP DF4 IS4 ProMRIVOLTALUX-DxBRAVA CRT DIlivia 7 VR-T DF-1 ProMRIUNIFYCrome HF Quad CRT-D MRI SureScanTARGET TIPProtego S 60TRANSVENE SVC LEADIdentityELLIPSE VR ICD, USIforia 7 VR-TEGIDA CRT DPrimo MRI DR SureScanLinox Smart TD 65/16FLEXION PERMANENT PACING LEADINOGEN MINI ICD VRIntica Neo 5 VR-T DX DF-1 ProMRIATRIAL LEADBioMonitor IVLinox Smart S 60LEAD
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Get Early AccessUnderstanding 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.
How a safety signal is detected
What the "Active Signals" count above means and the methods that separate a real signal from noise.
Post-market surveillance: a practical guide
Where MAUDE fits in the wider regulatory picture and the data sources teams rely on.
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.