Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

FDA product code NIK · Class 3 · 195 devices · 62,413 reports · 1,219 deaths reported · 71 devices named in recalls

• Amplia MRI™ Quad CRT-D SureScan™ DTMB1Q1

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall1 death61 reports
• Unify Assura™ CD3257-40

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  4 deaths108 reports
• Compia MRI™ Quad CRT-D SureScan™ DTMC1QQ

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall56 reports
• Secura® VR D224VRC

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death101 reports
• Protecta™ XT CRT-D D314TRM

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death99 reports
• Consulta® CRT-D D224TRK

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 deaths98 reports
• Maximo® II DR D284DRG

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death91 reports
• Viva™ XT CRT-D DTBA1D4

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall39 reports
• UNIFY™ CD3231-40Q

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 deaths86 reports
• Quadra Assura™ CD3265-40

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 deaths83 reports
• EASYTRAK® 2 4517

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  75 reports
• Acticor 7 HF-T DF4 IS-1 ProMRI 429523

  BIOTRONIK SE & Co. KG · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  73 reports
• Compia MRI™ CRT-D SureScan™ DTMC1D1

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall1 death22 reports
• Intica 7 HF-T QP DF-1 IS4 ProMRI 404629

  BIOTRONIK SE & Co. KG · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  4 deaths72 reports
• Gallant™ CDHFA500T

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death71 reports
• Viva™ Quad XT CRT-D DTBA1QQ

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall15 reports
• Viva™ XT CRT-D DTBA1D4

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall2 deaths15 reports
• Unify Quadra™ CD3249-40

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  6 deaths65 reports
• Viva™ Quad S CRT-D DTBB1QQ

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall1 death12 reports
• Viva™ S CRT-D DTBB1D1

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall12 reports
• Compia MRI™ CRT-D SureScan™ DTMC1D1

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall12 reports
• Itrevia 7 HF-T DF-1 393014

  BIOTRONIK SE & Co. KG · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 deaths60 reports
• Claria MRI™ Quad CRT-D SureScan™ DTMA1Q1

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 deaths59 reports
• Inventra 7 HF-T QP DF4 IS4 393012

  BIOTRONIK SE & Co. KG · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  59 reports
• Viva™ S CRT-D DTBB1D4

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall8 reports
• Viva™ Quad S CRT-D DTBB1Q1

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall1 death8 reports
• Claria MRI™ CRT-D SureScan™ DTMA1D4

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death58 reports
• PLATINIUM CRT-D 1711

  Microport Crm Srl · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall5 reports
• PLATINIUM CRT-D 1741

  Microport Crm Srl · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall4 reports
• Amplia MRI™ CRT-D SureScan™ DTMB1D4

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  53 reports
• Unify Assura™ CD3257-40Q

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 deaths52 reports
• Intica Neo 7 HF-T DF-1 IS-1 ProMRI 429553

  BIOTRONIK SE & Co. KG · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death51 reports
• Merlin.net MN5000

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall0 reports
• Quartet™ 1456Q

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death49 reports
• Quartet™ 1458QL

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  44 reports
• Promote™ CD3211-36Q

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 deaths42 reports
• Iperia 7 HF-T DF-1 ProMRI 393007

  BIOTRONIK SE & Co. KG · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  41 reports
• Protecta™ CRT-D D334TRG

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  39 reports
• EASYTRAK® 2 IS-1 4543

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  36 reports
• Iperia 7 HF-T DF4 ProMRI 393009

  BIOTRONIK SE & Co. KG · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  35 reports
• Protecta™ DR D334DRM

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death34 reports
• Itrevia 7 HF-T QP DF4 IS4 401662

  BIOTRONIK SE & Co. KG · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 deaths34 reports
• EASYTRAK® 3 4525

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  30 reports
• Intica 7 HF-T DF-1 IS-1 ProMRI 404627

  BIOTRONIK SE & Co. KG · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 deaths30 reports
• EASYTRAK® 2 IS-1 4542

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  29 reports
• Intica Neo 7 HF-T QP DF-1 IS4 ProMRI 429552

  BIOTRONIK SE & Co. KG · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death28 reports
• Allure Quadra™ PM3140

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  28 reports
• Secura® DR D204DRM

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  24 reports
• Maximo® II CRT-D D284TRK

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  23 reports
• Promote™ CD3211-36

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  20 reports
• Protecta™ VR D334VRM

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death19 reports
• Amplia MRI™ CRT-D SureScan™ DTMB1D1

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  18 reports
• EASYTRAK® 3 4524

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  18 reports
• Merlin™ EX3100

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  18 reports
• Amplia MRI™ Quad CRT-D SureScan™ DTMB1Q1

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  16 reports
• QUADRA ASSURA MP™ CD3269-40Q

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  16 reports
• Compia MRI™ Quad CRT-D SureScan™ DTMC1QQ

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  15 reports
• Ilesto 7 HF-T DF-1 383547

  BIOTRONIK SE & Co. KG · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death15 reports
• Secura® VR D204VRM

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  14 reports
• Rivacor 5 HF-T QP DF4 IS4 ProMRI 429561

  BIOTRONIK SE & Co. KG · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death14 reports
• Neutrino™ CDHFA600D

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death14 reports
• VIGILANT™ X4 CRT-D G248

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  11 reports
• Itrevia 7 HF-T 393016

  BIOTRONIK SE & Co. KG · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  11 reports
• Allure™ PM3120

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  11 reports
• Lumax 740 HF-T 365608

  BIOTRONIK SE & Co. KG · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  10 reports
• ORIGEN™ CRT-D G051

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  9 reports
• ORIGEN™ X4 CRT-D G058

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  5 reports
• Promote® RF

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death5 reports
• QUADRA ASSURA MP™ CD3269-40

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  5 reports
• ORIGEN™ CRT-D G050

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  4 reports
• Promote® 3107-36

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  4 reports
• Promote Accel™ CD3215-36Q

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  4 reports
• Entrant™ CDHFA300T

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death4 reports
• Paradym RF CRT-D 9750

  Microport Crm Srl · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  4 reports
• Iperia 7 HF-T QP DF4 IS4 401658

  BIOTRONIK SE & Co. KG · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 reports
• Intica Neo 5 HF-T QP DF-1 IS4 ProMRI 429566

  BIOTRONIK SE & Co. KG · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death3 reports
• Quartet™ 1458QL

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 reports
• Protecta™ CRT-D D334TRG

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 reports
• Protecta™ XT CRT-D D314TRG

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 reports
• EASYTRAK® 2 IS-1 4544

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 reports
• EASYTRAK® 2 IS-1 4544

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 reports
• Rivacor 5 HF-T DF4 IS-1 ProMRI 429562

  BIOTRONIK SE & Co. KG · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 reports
• Rivacor 3 HF-T QP DF4 IS4 ProMRI 429571

  BIOTRONIK SE & Co. KG · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 reports
• Entrant™ CDHFA300B

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 reports
• Compia MRI™ CRT-D SureScan™ DTMC1D1

  Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 report
• EASYTRAK® 3 4527

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 report
• Ilesto 7 HF-T DF4 383549

  BIOTRONIK SE & Co. KG · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 report
• Ilesto 5 HF-T 383550

  BIOTRONIK SE & Co. KG · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 report
• Itrevia 5 HF-T 393066

  BIOTRONIK SE & Co. KG · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 report
• Itrevia 5 HF-T QP DF4 IS4 402659

  BIOTRONIK SE & Co. KG · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 report
• Ilivia Neo 7 HF-T QP DF-1 IS4 ProMRI 429527

  BIOTRONIK SE & Co. KG · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 report
• Rivacor 7 HF-T DF4 IS-1 ProMRI 429533

  BIOTRONIK SE & Co. KG · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 report
• Intica Neo 5 HF-T DF-1 IS-1 ProMRI 429567

  BIOTRONIK SE & Co. KG · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 report
• Promote® RF

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 report
• Promote Accel™ CD3215-36

  St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 report