Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

FDA product code NVN · Class 3 · 113 devices · 121,800 reports · 1,628 deaths reported · 1 devices named in recalls

• Tendril™ STS

  St. Jude Medical, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  438 deaths19,632 reports
• Tendril™ STS

  St. Jude Medical, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  200 deaths12,708 reports
• INGEVITY™ MRI 7741

  Boston Scientific Corporation · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  36 deaths7,874 reports
• INGEVITY™+ 7841

  Boston Scientific Corporation · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  15 deaths7,419 reports
• Tendril™ STS

  St. Jude Medical, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  190 deaths6,776 reports
• INGEVITY™+ 7842

  Boston Scientific Corporation · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  21 deaths5,995 reports
• SelectSecure™ MRI SureScan™ 383069

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  50 deaths5,027 reports
• CapSureFix Novus MRI™ SureScan® 5076-45

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  40 deaths5,000 reports
• INGEVITY™ MRI 7742

  Boston Scientific Corporation · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  24 deaths3,967 reports
• Solia S 53 377177

  BIOTRONIK SE & Co. KG · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  17 deaths3,813 reports
• INGEVITY™ MRI 7740

  Boston Scientific Corporation · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  11 deaths3,257 reports
• Tendril MRI™ LPA1200M-52

  St. Jude Medical, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  111 deaths2,915 reports
• CapSureFix MRI™ SureScan™ 5086MRI52

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  18 deaths2,671 reports
• INGEVITY™+ 7840

  Boston Scientific Corporation · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  14 deaths2,640 reports
• CapSureFix Novus MRI™ SureScan® 5076-52

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  16 deaths2,051 reports
• CapSureFix MRI™ SureScan™ 5086MRI45

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  10 deaths1,827 reports
• Tendril MRI™ LPA1200M-58

  St. Jude Medical, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  61 deaths1,801 reports
• Solia S 60 377179

  BIOTRONIK SE & Co. KG · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  6 deaths1,761 reports
• CAPSUREFIX® NOVUS 407645

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  12 deaths1,708 reports
• Solia S 45 377176

  BIOTRONIK SE & Co. KG · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  6 deaths1,702 reports
• CapSureFix Novus MRI™ SureScan™ 407658

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  33 deaths1,539 reports
• CapSure Sense MRI™ SureScan™ 457445

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  16 deaths1,416 reports
• Tendril MRI™ LPA1200M-46

  St. Jude Medical, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  52 deaths1,125 reports
• DEXTRUS 4136

  BIOTRONIK SE & Co. KG · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  5 deaths1,084 reports
• Optisense™ 1999-52

  St. Jude Medical, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  16 deaths1,019 reports
• UltiPace™ LPA1231

  St. Jude Medical, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  19 deaths952 reports
• Setrox S 53 350974

  BIOTRONIK SE & Co. KG · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  1 death873 reports
• UltiPace™ LPA1231

  St. Jude Medical, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  7 deaths849 reports
• Capsure® EPI 4968-25

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  13 deaths843 reports
• CapSure Sense MRI™ SureScan™ 407458

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  8 deaths766 reports
• CapSureFix Novus MRI™ SureScan® 5076-58

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  6 deaths698 reports
• UltiPace™ LPA1231

  St. Jude Medical, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  8 deaths657 reports
• DEXTRUS 4137

  BIOTRONIK SE & Co. KG · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  3 deaths560 reports
• Optisense™ 1999-46

  St. Jude Medical, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  17 deaths521 reports
• DEXTRUS 4135

  BIOTRONIK SE & Co. KG · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  2 deaths490 reports
• INGEVITY™ MRI 7732

  Boston Scientific Corporation · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  3 deaths466 reports
• Capsure® EPI 4968-60

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  12 deaths459 reports
• Tendril™ STS

  St. Jude Medical, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  6 deaths433 reports
• INGEVITY™ MRI 7736

  Boston Scientific Corporation · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  1 death388 reports
• INGEVITY™ MRI 7731

  Boston Scientific Corporation · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  5 deaths386 reports
• Setrox S 60 350975

  BIOTRONIK SE & Co. KG · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  347 reports
• CapSure®Z Novus 5554-45

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  1 death320 reports
• CAPSURE® SENSE 457445

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  1 death300 reports
• Capsure®SP Novus 5092-52

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  4 deaths294 reports
• UltiPace™ LPA1231

  St. Jude Medical, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  3 deaths281 reports
• Capsure®Z Novus 5054-58

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  2 deaths273 reports
• INGEVITY™ MRI 7735

  Boston Scientific Corporation · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  2 deaths263 reports
• Adapta™ L ADDRL1

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  1 recall44 deaths200 reports
• Adapta™ ADSR01

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  8 deaths237 reports
• CapSure®SP Novus 4592-45

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  2 deaths237 reports
• CAPSUREFIX® NOVUS 407652

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  1 death224 reports
• Capsure® EPI 4965-35

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  207 reports
• CapSure Sense® 457445

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  202 reports
• Setrox S 45 350973

  BIOTRONIK SE & Co. KG · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  1 death201 reports
• Adapta® L ADDRL1

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  4 deaths175 reports
• CAPSURE® SENSE 407458

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  3 deaths151 reports
• CapSureFix Novus MRI™ SureScan® 5076-65

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  3 deaths148 reports
• Capsure® EPI 4965-25

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  4 deaths133 reports
• Capsure® EPI 4965-15

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  1 death129 reports
• SELECTSECURE™ 383069

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  4 deaths128 reports
• Selox ST 53 346366

  BIOTRONIK SE & Co. KG · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  106 reports
• CapSureFix Novus MRI™ SureScan™ 5076-58

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  3 deaths99 reports
• CAPSUREFIX® NOVUS 5076-65

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  98 reports
• Solia JT 45

  BIOTRONIK SE & Co. KG · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  87 reports
• Solia T 60

  BIOTRONIK SE & Co. KG · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  1 death74 reports
• Selox JT 45 346369

  BIOTRONIK SE & Co. KG · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  1 death72 reports
• Solia JT 53

  BIOTRONIK SE & Co. KG · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  1 death67 reports
• CapSure Sense® 407458

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  57 reports
• Solia T 53

  BIOTRONIK SE & Co. KG · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  54 reports
• Selox ST 60 346367

  BIOTRONIK SE & Co. KG · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  1 death47 reports
• SELECTSECURE™ 383049

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  45 reports
• CAPSUREFIX® NOVUS 5076-35

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  40 reports
• Adapta™ ADSR01

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  36 reports
• Capsure® EPI 4965-50

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  35 reports
• Safio S 60 370946

  BIOTRONIK SE & Co. KG · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  35 reports
• CapSure Sense® 407458

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  34 reports
• Optisense™ 1999-40

  St. Jude Medical, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  2 deaths31 reports
• Safio S 53 370945

  BIOTRONIK SE & Co. KG · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  23 reports
• Tendril™ STS

  St. Jude Medical, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  23 reports
• Selox JT 53 346368

  BIOTRONIK SE & Co. KG · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  21 reports
• Solia CSP S 60 468460

  BIOTRONIK SE & Co. KG · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  21 reports
• CapSureFix Novus MRI™ SureScan™ 407665

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  18 reports
• CapSure Sense MRI™ SureScan™ 457445

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  15 reports
• CapSureFix Novus MRI™ SureScan® 5076-35

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  15 reports
• CapSure Sense MRI™ SureScan™ 407458

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  14 reports
• CapSureFix Novus MRI™ SureScan® 5076-85

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  1 death13 reports
• CapSureFix Novus MRI™ SureScan® 5076-65

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  11 reports
• CAPSURE® VDD-2 5038-58

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  10 reports
• Entrant™ CDHFA300D

  St. Jude Medical, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  8 reports
• Tilda R 53 US 382889

  BIOTRONIK SE & Co. KG · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  7 reports
• SELECTSECURE™ 383074

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  1 death6 reports
• SUREFIX® 5072-52

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  5 reports
• Siello T 60

  BIOTRONIK SE & Co. KG · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  5 reports
• CAPSURE® VDD-2 5038S-52

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  4 reports
• CAPSURE® Z NOVUS 5554-45

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  4 reports
• CapSureFix Novus MRI™ SureScan™ 407685

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  4 reports
• CAPSURE® SENSE 407352

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  4 reports
• Siello JT 53

  BIOTRONIK SE & Co. KG · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  4 reports
• TILDA R 60

  BIOTRONIK SE & Co. KG · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  4 reports
• CAPSURE® VDD-2 5038S-58

  Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  3 reports