Cardiac Rhythm Management Adverse Event Data
Pacemakers, ICDs, CRT devices, leads, and insertable cardiac monitors — adverse event trends and safety signals.
Total Reports
456,724
Devices Tracked
200
Reports (30d)
6,964
Active Signals
528
Monthly Report Volume
Event Type Breakdown
Devices in CRM
| Device | Total Reports | Last 30d |
|---|---|---|
| 35,769 | 542 | |
CAPSUREFIX® NOVUSDTB | 29,376 | 408 |
| 27,559 | 575 | |
| 26,882 | 427 | |
| 20,514 | 296 | |
| 17,096 | 336 | |
CAPSUREFIX® NOVUSDTB | 9,802 | 177 |
| 9,615 | 25 | |
LINQ II™MXD | 9,341 | 365 |
| 8,363 | 57 | |
Gallant™NIK | 8,267 | 159 |
| 7,218 | 162 | |
Durata™NVY | 5,595 | 57 |
| 5,463 | 44 | |
Micra™PNJ | 5,261 | 28 |
Quartet™NIK | 5,070 | 53 |
CAPSUREFIX® NOVUSDTB | 5,034 | 87 |
| 4,735 | 51 | |
| 4,549 | 22 | |
| 4,528 | 22 | |
Durata™NVY | 4,337 | 49 |
Micra™ AVPNJ | 3,947 | 30 |
Capsurefix® NovusNVY | 3,666 | 45 |
| 3,485 | 40 | |
| 3,454 | 32 |
1–25 of 200 devices
1 / 8
All CRM device pages (210)
CAPSUREFIX NovusEMBLEM S-ICDSprint Quattro Secure S MRI SureScanCapSureFix Novus MRI SureScanDurataQuadra Assura MPLINQ IIGallant CRT-DQuartetFINELINE II EZ SteroxSPRINT QUATTRO SECURE DXAC/DSPMicraAveirPlexa ProMRIOptisureEvera MRI XT DR SureScanSprint Quattro SecureUnify AssuraPERMANENT PACEMAKER ELECTRODESPRINT FIDELISClaria MRI Quad CRT-D SureScanGallant ICDMicra AVIsoflexCAPSURE SP NovusENDOTAK RELIANCE SGRELIANCE 4-FRONTCapSure SenseQuadra AssuraCapsure EPIENDOTAK RELIANCE GFORTIFY ASSURA VR ICD, USMicra AV2FLEXTENDSprint Quattro Secure MRI SureScanPERMANENT DEFIBRILLATOR ELECTRODESVIGILANT X4 CRT-DCobalt XT HF Quad CRT-D MRI SureScanCobalt XT DR MRI SureScanRESONATE X4 CRT-DCapsurefix DXAC/DSPRIATA ACTIVE FIXATIONSprint Quattro Secure SVALITUDE X4 CRT-PVisia AF MRI VR SureScanRESONATE EL ICD DRVIGILANT EL ICD DRVISIONIST X4 CRT-PPercepta Quad CRT-P MRI SureScanUnidentified MEDTRONIC, INC.NeutrinoELLIPSE DR ICD, USEvera XT DREpsila EV MRI SureScanProtego S 65Quadra Allure MPSprint QuattroDYNAGEN EL ICD DRAUTOGENMOMENTUM EL ICD DRLinox Smart S DX 65/15INOGEN X4 CRT-DMOMENTUM CRT-DViva XT CRT-DAmplia MRI Quad CRT-D SureScanLinox Smart S 65INOGEN EL ICD DRCobalt HF Quad CRT-D MRI SureScanDYNAGEN X4 CRT-DINOGEN EL ICD VRVIGILANT EL ICD VRFINELINE II SteroxTENDRIL MRIClaria MRI CRT-D SureScanRESONATE EL ICD VRENDOTAK RELIANCE SINVIVEDYNAGEN EL ICD VRMicra VR2BioMonitor IIICobalt DR MRI SureScanLinox Smart SD 65/18Percepta CRT-P MRI SureScanMerlinCobalt XT VR MRI SureScanEvera XT VREvera MRI S DR SureScanEASYTRAK 2 IS-1MOMENTUM X4 CRT-DViva Quad XT CRT-DASSURITY MRIActicor 7 VR-T DX DF4 ProMRIInventra 7 VR-T DX DF-1 ProMRILUX-Dx Insertable Cardiac MonitorMEDTRONIC LEADAurora EV-ICD MRI SureScanCobalt XT HF CRT-D MRI SureScanVALITUDE CRT-PDEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIOLinox Smart SD 65/16VISIONIST CRT-PENDOTAK RELIANCERESONATE HF CRT-DCapSureZ NovusSprint Quattro Secure S DXAC/DSPLinox Smart S DX 65/17ENDURITY PACEMAKER, DR, MRI RESTRICTEDIperia 7 VR-T DX DF-1 ProMRICompia MRI CRT-D SureScanRESONATE HF ICD DRBioMonitor IIImAllureDYNAGEN CRT-DCapsureSP NovusMOMENTUM EL ICD VRIntica 7 VR-T DX DF-1 ProMRITRANSVENOUS LEADMyopore Sutureless Myocardial Pacing LeadLUX-Dx II+Cobalt VR MRI SureScanEntrantAllure QuadraSQ-RX PULSE GENERATORRIATA ST OPTIM LEADCRYSTALLINE ACTFIXINOGEN CRT-DIforia 5 VR-TRivacor 7 HF-T QP DF4 IS4 ProMRIItrevia 5 VR-TLinox Smart SD 60/16Evera S DRAmplia MRI CRT-D SureScanUnify QuadraDYNAGEN MINI ICD DRPERCIVA ICD DRProtecta VRFORTIFY VR, U1.6 SJ4 IDPLATINIUMINTUAVictoryEvera S VRVerityLumax 740 VR-TRIATA ST PASSIVE FIXATIONIperia 7 VR-TViva Quad S CRT-DVisia AF MRI S VR SureScanSolara Quad CRT-P MRI SureScanACUITY SteerableIlesto 7 VR-T DX DF-1 USCHARISMAProtecta DREvera MRI XT VR SureScanIlivia 7 VR-T DF4 ProMRIPamira S DX 65/15Protego SD 65/18The Q-TRAK Subcutaneous ElectrodeActicor 7 HF-T QP DF4 IS4 ProMRISolara CRT-P MRI SureScanCobalt HF CRT-D MRI SureScanSerena Quad CRT-P MRI SureScanEpsila EVSprint Quattro MRI SureScanLumax 740 VR-T DXRA LEADProtecta XT DRSerena CRT-P MRI SureScanRV LEADMaximo II VRCAPSUREFIX LEADCARELINK SYSTEMRV LEADPERCIVA ICD VRLinox Smart TD 65/16CAPSUREFIXSUBCUTANEOUS, UNIPOLAR LEADALIZEACompia MRI Quad CRT-D SureScanViva S CRT-DIntica Neo 5 VR-T DF-1 ProMRICrome DR MRI SureScanDYNAGEN MINI ICD VREvera MRI S VR SureScanLATITUDE COMMUNICATORIforia 7 VR-T DX DF-1 USELLIPSE VREASYTRAK 2BioMonitor 2-AFPamira S 65Edora 8 HF-T QPRESONATE HF ICD VRTendrilProtego DF-1Ilivia 7 HF-T QP DF4 IS4 ProMRICrome VR MRI SureScanVOLTAUNIFYTARGET TIPProtecta XT CRT-DLUX-DxIlivia 7 VR-T DF-1 ProMRIIdentityProtego S 60Iforia 7 VR-TPrimo MRI DR SureScanCrome HF Quad CRT-D MRI SureScanProtecta XT VRLinox Smart S 60INOGEN MINI ICD VRVisia AF VR
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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.