Pulse generator, permanent, implantable
FDA product code NVZ · Class 3 · 168 devices · 33,334 reports · 928 deaths reported · 48 devices named in recalls
- Assurity™ PM2240St. Jude Medical, Inc. · Pulse generator, permanent, implantable1 recall84 deaths4,076 reports
- Fortify Assura™ CD2357-40QSt. Jude Medical, Inc. · Pulse generator, permanent, implantable63 deaths3,571 reports
- Advisa DR MRI™ SureScan® A2DR01Medtronic, Inc. · Pulse generator, permanent, implantable51 deaths2,298 reports
- Fortify Assura™ CD1357-40QSt. Jude Medical, Inc. · Pulse generator, permanent, implantable35 deaths1,933 reports
- Ellipse™ CD2411-36QSt. Jude Medical, Inc. · Pulse generator, permanent, implantable42 deaths1,498 reports
- Fortify Assura™ CD2357-40CSt. Jude Medical, Inc. · Pulse generator, permanent, implantable25 deaths1,378 reports
- Accent® DR RFSt. Jude Medical, Inc. · Pulse generator, permanent, implantable73 deaths1,370 reports
- Edora 8 DR-T 407145BIOTRONIK SE & Co. KG · Pulse generator, permanent, implantable10 deaths982 reports
- Zephyr™ XL DRSt. Jude Medical, Inc. · Pulse generator, permanent, implantable24 deaths944 reports
- Revo MRI™ SureScan™ RVDR01Medtronic, Inc. · Pulse generator, permanent, implantable4 deaths721 reports
- Visia AF MRI™ VR SureScan™ DVFB1D4Medtronic, Inc. · Pulse generator, permanent, implantable1 recall10 deaths645 reports
- Ellipse™ CD1411-36QSt. Jude Medical, Inc. · Pulse generator, permanent, implantable17 deaths694 reports
- FORTIFY™ CD2231-40QSt. Jude Medical, Inc. · Pulse generator, permanent, implantable15 deaths623 reports
- FORTIFY™ CD1231-40QSt. Jude Medical, Inc. · Pulse generator, permanent, implantable3 deaths618 reports
- Fortify Assura™ CD1357-40CSt. Jude Medical, Inc. · Pulse generator, permanent, implantable18 deaths615 reports
- Visia AF MRI™ VR SureScan™ DVFB1D4Medtronic, Inc. · Pulse generator, permanent, implantable1 recall12 deaths554 reports
- Ellipse™ CD2411-36CSt. Jude Medical, Inc. · Pulse generator, permanent, implantable17 deaths569 reports
- Visia AF MRI™ VR SureScan™ DVFB1D4Medtronic, Inc. · Pulse generator, permanent, implantable2 recalls10 deaths453 reports
- Cobalt™ VR MRI SureScan™ DVPB3D4Medtronic, Inc. · Pulse generator, permanent, implantable4 recalls6 deaths287 reports
- Azure™ XT SR MRI SureScan™ W1SR01Medtronic, Inc. · Pulse generator, permanent, implantable11 deaths425 reports
- Adapta™ ADDR01Medtronic, Inc. · Pulse generator, permanent, implantable1 recall84 deaths364 reports
- Assurity™ PM1240St. Jude Medical, Inc. · Pulse generator, permanent, implantable1 recall20 deaths306 reports
- Evera MRI™ XT DR SureScan™ DDMB1D1Medtronic, Inc. · Pulse generator, permanent, implantable2 recalls9 deaths253 reports
- Merlin@home™ EX1150St. Jude Medical, Inc. · Pulse generator, permanent, implantable353 reports
- FORTIFY™ CD2231-40St. Jude Medical, Inc. · Pulse generator, permanent, implantable4 deaths334 reports
- FORTIFY™ CD1231-40St. Jude Medical, Inc. · Pulse generator, permanent, implantable7 deaths333 reports
- Sensia™ SESR01Medtronic, Inc. · Pulse generator, permanent, implantable5 deaths315 reports
- Endurity™ PM2160St. Jude Medical, Inc. · Pulse generator, permanent, implantable1 recall2 deaths237 reports
- Cobalt™ DR MRI SureScan™ DDPB3D1Medtronic, Inc. · Pulse generator, permanent, implantable3 recalls2 deaths125 reports
- Fortify Assura™ CD2257-40QSt. Jude Medical, Inc. · Pulse generator, permanent, implantable4 deaths269 reports
- Fortify Assura™ CD1257-40QSt. Jude Medical, Inc. · Pulse generator, permanent, implantable4 deaths250 reports
- Ellipse™ CD1411-36CSt. Jude Medical, Inc. · Pulse generator, permanent, implantable14 deaths248 reports
- Advisa SR MRI™ SureScan™ A3SR01Medtronic, Inc. · Pulse generator, permanent, implantable16 deaths230 reports
- Adapta® ADDR01Medtronic, Inc. · Pulse generator, permanent, implantable7 deaths229 reports
- Adapta™ L ADDRL1Medtronic, Inc. · Pulse generator, permanent, implantable1 recall38 deaths177 reports
- Visia AF MRI™ VR SureScan™ DVFB1D4Medtronic, Inc. · Pulse generator, permanent, implantable1 recall2 deaths173 reports
- Zephyr® DRSt. Jude Medical, Inc. · Pulse generator, permanent, implantable9 deaths219 reports
- Eluna 8 DR-T ProMRI 394969BIOTRONIK SE & Co. KG · Pulse generator, permanent, implantable1 death217 reports
- Accent™ DRSt. Jude Medical, Inc. · Pulse generator, permanent, implantable20 deaths214 reports
- Visia AF MRI™ VR SureScan™ DVFB1D1Medtronic, Inc. · Pulse generator, permanent, implantable2 recalls1 death106 reports
- Crome™ DR MRI SureScan™ DDPC3D4Medtronic, Inc. · Pulse generator, permanent, implantable3 recalls1 death52 reports
- Fortify Assura™ CD2257-40St. Jude Medical, Inc. · Pulse generator, permanent, implantable3 deaths190 reports
- Consulta® CRT-P C4TR01Medtronic, Inc. · Pulse generator, permanent, implantable4 deaths179 reports
- Evera MRI™ XT DR SureScan™ DDMB1D1Medtronic, Inc. · Pulse generator, permanent, implantable1 recall3 deaths124 reports
- Amvia Edge DR-T 460163BIOTRONIK SE & Co. KG · Pulse generator, permanent, implantable170 reports
- Crome™ VR MRI SureScan™ DVPC3D4Medtronic, Inc. · Pulse generator, permanent, implantable3 recalls18 reports
- Adapta™ S ADDRS1Medtronic, Inc. · Pulse generator, permanent, implantable1 recall31 deaths117 reports
- Crome™ DR MRI SureScan™ DDPC3D1Medtronic, Inc. · Pulse generator, permanent, implantable3 recalls16 reports
- Accent™ SR RFSt. Jude Medical, Inc. · Pulse generator, permanent, implantable12 deaths164 reports
- Zephyr™ XL SRSt. Jude Medical, Inc. · Pulse generator, permanent, implantable2 deaths161 reports
- Assurity™ PM2260St. Jude Medical, Inc. · Pulse generator, permanent, implantable1 recall109 reports
- Versa™ VEDR01Medtronic, Inc. · Pulse generator, permanent, implantable1 recall22 deaths98 reports
- Evera MRI™ S DR SureScan® DDMC3D4Medtronic, Inc. · Pulse generator, permanent, implantable1 recall2 deaths83 reports
- Ellipse™ CD2311-36QSt. Jude Medical, Inc. · Pulse generator, permanent, implantable3 deaths124 reports
- Current™ CD1211-36QSt. Jude Medical, Inc. · Pulse generator, permanent, implantable4 deaths121 reports
- Visia AF MRI™ S VR SureScan™ DVFC3D4Medtronic, Inc. · Pulse generator, permanent, implantable1 recall1 death70 reports
- Evera MRI™ S DR SureScan® DDMC3D4Medtronic, Inc. · Pulse generator, permanent, implantable1 recall2 deaths68 reports
- Crome™ VR MRI SureScan™ DVPC3D1Medtronic, Inc. · Pulse generator, permanent, implantable2 recalls12 reports
- Ellipse™ CD1311-36QSt. Jude Medical, Inc. · Pulse generator, permanent, implantable4 deaths109 reports
- Visia AF MRI™ S VR SureScan™ DVFC3D4Medtronic, Inc. · Pulse generator, permanent, implantable2 recalls8 reports
- Sustain™ PM2136St. Jude Medical, Inc. · Pulse generator, permanent, implantable107 reports
- Evia DR-T 359529BIOTRONIK SE & Co. KG · Pulse generator, permanent, implantable2 deaths93 reports
- Edora 8 SR-T 407157BIOTRONIK SE & Co. KG · Pulse generator, permanent, implantable1 death93 reports
- Endurity™ PM1160St. Jude Medical, Inc. · Pulse generator, permanent, implantable1 recall1 death42 reports
- Zephyr® SRSt. Jude Medical, Inc. · Pulse generator, permanent, implantable4 deaths90 reports
- MyCareLink™ 24950JMedtronic, Inc. · Pulse generator, permanent, implantable1 recall39 reports
- MyCareLink™ 24950KMedtronic, Inc. · Pulse generator, permanent, implantable1 recall38 reports
- Accent™ SRSt. Jude Medical, Inc. · Pulse generator, permanent, implantable8 deaths88 reports
- Fortify Assura™ CD1257-40St. Jude Medical, Inc. · Pulse generator, permanent, implantable2 deaths86 reports
- MyCareLink™ 24950KLQMedtronic, Inc. · Pulse generator, permanent, implantable1 recall32 reports
- Ellipse™ DRSt. Jude Medical, Inc. · Pulse generator, permanent, implantable1 death79 reports
- Current™ CD1211-36St. Jude Medical, Inc. · Pulse generator, permanent, implantable2 deaths76 reports
- Visa AF MRI™ S VR SureScan™ DVFC3D1Medtronic, Inc. · Pulse generator, permanent, implantable1 recall1 death22 reports
- Evera™ XT DR DDBB1D4Medtronic, Inc. · Pulse generator, permanent, implantable1 recall20 reports
- MyCareLink™ 24950JLQMedtronic, Inc. · Pulse generator, permanent, implantable1 recall18 reports
- MyCareLink™ 24950MMedtronic, Inc. · Pulse generator, permanent, implantable65 reports
- Visia AF™ VR DVAB1D4Medtronic, Inc. · Pulse generator, permanent, implantable1 recall13 reports
- Evera MRI™ S DR SureScan™ DDMC3D1Medtronic, Inc. · Pulse generator, permanent, implantable1 recall13 reports
- MyCareLink™ 24950JMedtronic, Inc. · Pulse generator, permanent, implantable1 recall12 reports
- Visia AF™ VR DVAB1D4Medtronic, Inc. · Pulse generator, permanent, implantable1 recall11 reports
- Evera™ XT DR DDBB1D1Medtronic, Inc. · Pulse generator, permanent, implantable1 recall11 reports
- MyCareLink™ 24950JLQMedtronic, Inc. · Pulse generator, permanent, implantable1 recall10 reports
- MyCareLink™ 24950KLQMedtronic, Inc. · Pulse generator, permanent, implantable1 recall10 reports
- Adapta™ ADDR06Medtronic, Inc. · Pulse generator, permanent, implantable1 recall2 deaths7 reports
- Adapta™ ADDR03Medtronic, Inc. · Pulse generator, permanent, implantable1 recall1 death6 reports
- Visia AF MRI™ S VR SureScan™ DVFC3D1Medtronic, Inc. · Pulse generator, permanent, implantable1 recall6 reports
- Adapta™ S ADDRS1PMedtronic, Inc. · Pulse generator, permanent, implantable1 recall1 death4 reports
- Evera MRI™ XT VR SureScan® DVMB1D4Medtronic, Inc. · Pulse generator, permanent, implantable1 recall2 reports
- Entovis DR-T ProMRI 371992BIOTRONIK SE & Co. KG · Pulse generator, permanent, implantable52 reports
- Current® VR RFSt. Jude Medical, Inc. · Pulse generator, permanent, implantable2 deaths52 reports
- Current™ CD2211-36QSt. Jude Medical, Inc. · Pulse generator, permanent, implantable3 deaths52 reports
- Merlin@home™ EX1100St. Jude Medical, Inc. · Pulse generator, permanent, implantable1 recall2 reports
- MyCareLink™ 24950JLQMedtronic, Inc. · Pulse generator, permanent, implantable1 recall1 report
- Adapta™ ADVDD01Medtronic, Inc. · Pulse generator, permanent, implantable1 recall1 report
- Sensia™ SEDR01Medtronic, Inc. · Pulse generator, permanent, implantable1 recall0 reports
- Etrinsa 8 DR-T 394931BIOTRONIK SE & Co. KG · Pulse generator, permanent, implantable50 reports
- Sustain™ PM2134St. Jude Medical, Inc. · Pulse generator, permanent, implantable1 death43 reports
- Current™ CD2211-36St. Jude Medical, Inc. · Pulse generator, permanent, implantable2 deaths42 reports
- Revo MRI™ SureScan™ RVDR01Medtronic, Inc. · Pulse generator, permanent, implantable2 deaths41 reports
- MyCareLink™ 24950MMedtronic, Inc. · Pulse generator, permanent, implantable41 reports