BIOTRONIK SE & Co. KG

219 devices · 29,407 adverse event reports · 144 deaths reported · 0 devices named in recalls

Counts reflect reports that name each device's exact identifier. Larger companies sell more devices, so totals should not be read as a safety ranking.

All BIOTRONIK SE & Co. KG devices

• Solia S 53 377177

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  17 deaths3,813 reports
• Solia S 60 377179

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  6 deaths1,761 reports
• Solia S 45 377176

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  6 deaths1,702 reports
• Plexa ProMRI S 65

  Permanent defibrillator electrodes
  9 deaths1,592 reports
• Sentus ProMRI OTW QP L-85/49 408719

  Drug eluting permanent left ventricular (lv) pacemaker electrode
  7 deaths1,385 reports
• DEXTRUS 4136

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  5 deaths1,084 reports
• Edora 8 DR-T 407145

  Pulse generator, permanent, implantable
  10 deaths982 reports
• Setrox S 53 350974

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  1 death873 reports
• Plexa ProMRI S DX 65/15

  Permanent defibrillator electrodes
  1 death762 reports
• BioMonitor III 436066

  RECORDER,EVENT,IMPLANTABLE CARDIAC,(WITH ARRHYTHMIA DETECTION)
  655 reports
• Plexa ProMRI DF-1 S DX 65/15

  Permanent defibrillator electrodes
  652 reports
• Linox Smart S DX 65/15 365500

  Permanent defibrillator electrodes
  1 death632 reports
• DEXTRUS 4137

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  3 deaths560 reports
• Acticor 7 VR-T DX DF4 ProMRI 429525

  Implantable cardioverter defibrillator (non-CRT)
  6 deaths550 reports
• Inventra 7 VR-T DX DF-1 ProMRI 399436

  Implantable cardioverter defibrillator (non-CRT)
  1 death534 reports
• Sentus ProMRI OTW QP S-85/49 406082

  Drug eluting permanent left ventricular (lv) pacemaker electrode
  1 death511 reports
• DEXTRUS 4135

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  2 deaths490 reports
• Protego S 65 379969

  Permanent defibrillator electrodes
  393 reports
• Iperia 7 VR-T DX DF-1 ProMRI 393032

  Implantable cardioverter defibrillator (non-CRT)
  374 reports
• BioMonitor IIIm 450218

  Recorder, event, implantable cardiac, (with arrhythmia detection)
  373 reports
• Setrox S 60 350975

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  347 reports
• Resilience 55

  Stimulator, spinal-cord, totally implanted for pain relief
  320 reports
• Intica 7 VR-T DX DF-1 ProMRI 404633

  Implantable cardioverter defibrillator (non-CRT)
  315 reports
• Plexa ProMRI SD 65/18

  Permanent defibrillator electrodes
  294 reports
• Linox Smart S DX 65/17 365501

  Permanent defibrillator electrodes
  290 reports
• Rivacor 7 DR-T DF4 ProMRI 429534

  DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
  2 deaths286 reports
• Iperia 7 DR-T DF4 ProMRI 392423

  DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
  3 deaths256 reports
• Rivacor 7 HF-T QP DF4 IS4 ProMRI 429532

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  5 deaths255 reports
• Linox Smart S 65 369818

  Permanent defibrillator electrodes
  237 reports
• Ilivia 7 DR-T DF4 ProMRI 404623

  DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
  2 deaths233 reports
• Eluna 8 DR-T ProMRI 394969

  Pulse generator, permanent, implantable
  1 death217 reports
• Pamira S DX 65/15 428775

  Permanent defibrillator electrodes
  212 reports
• Setrox S 45 350973

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  1 death201 reports
• Plexa ProMRI S 60 402265

  Permanent defibrillator electrodes
  1 death198 reports
• Plexa ProMRI S DX 65/17

  Permanent defibrillator electrodes
  197 reports
• Linox Smart SD 65/18 359067

  Permanent defibrillator electrodes
  1 death193 reports
• Prospera IPG

  Stimulator, spinal-cord, totally implanted for pain relief
  192 reports
• Plexa ProMRI DF-1 S DX 65/17

  Permanent defibrillator electrodes
  175 reports
• Amvia Edge DR-T 460163

  Pulse generator, permanent, implantable
  170 reports
• Ilesto 7 VR-T DX DF-1 US 383594

  Implantable cardioverter defibrillator (non-CRT)
  1 death157 reports
• BioMonitor 2-AF 398493

  RECORDER,EVENT,IMPLANTABLE CARDIAC,(WITH ARRHYTHMIA DETECTION)
  151 reports
• Acticor 7 HF-T QP DF4 IS4 ProMRI 429522

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death144 reports
• Sentus ProMRI OTW QP L-75/49 408718

  Drug eluting permanent left ventricular (lv) pacemaker electrode
  135 reports
• Ilivia 7 HF-T QP DF4 IS4 ProMRI 404621

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 deaths133 reports
• Protego SD 65/18 399410

  Permanent defibrillator electrodes
  122 reports
• Protego S 60 379970

  Permanent defibrillator electrodes
  113 reports
• Linox Smart SD 60/16 359065

  Permanent defibrillator electrodes
  107 reports
• Selox ST 53 346366

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  106 reports
• Edora 8 HF-T QP 407137

  Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  1 death98 reports
• Evia DR-T 359529

  Pulse generator, permanent, implantable
  2 deaths93 reports
• Iperia 7 DR-T DF-1 ProMRI 392409

  DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
  93 reports
• Edora 8 SR-T 407157

  Pulse generator, permanent, implantable
  1 death93 reports
• Solia JT 45

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  87 reports
• Sentus ProMRI OTW QP L-85 401183

  Drug eluting permanent left ventricular (lv) pacemaker electrode
  2 deaths83 reports
• Linox Smart SD 65/16 359066

  Permanent defibrillator electrodes
  1 death82 reports
• BioMonitor IV 471155

  Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
  82 reports
• Ilesto 7 DR-T DF-1 US 383562

  DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
  79 reports
• Ilivia 7 VR-T DF4 ProMRI 404626

  Implantable cardioverter defibrillator (non-CRT)
  1 death77 reports
• Solia T 60

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  1 death74 reports
• Ilivia 7 DR-T DF-1 ProMRI 404622

  DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
  74 reports
• Corox OTW-L 85-BP

  Drug eluting permanent left ventricular (lv) pacemaker electrode
  73 reports
• Acticor 7 HF-T DF4 IS-1 ProMRI 429523

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  73 reports
• Selox JT 45 346369

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  1 death72 reports
• Intica 7 HF-T QP DF-1 IS4 ProMRI 404629

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  4 deaths72 reports
• Resilience 75

  Stimulator, spinal-cord, totally implanted for pain relief
  72 reports
• Iforia 7 VR-T DX DF-1 US 390090

  Implantable cardioverter defibrillator (non-CRT)
  71 reports
• Solia JT 53

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  1 death67 reports
• Plexa ProMRI DF-1 S 65

  Permanent defibrillator electrodes
  2 deaths65 reports
• Pamira S 60 428768

  Permanent defibrillator electrodes
  65 reports
• Itrevia 7 HF-T DF-1 393014

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 deaths60 reports
• Pamira S 65 428769

  Permanent defibrillator electrodes
  60 reports
• Inventra 7 HF-T QP DF4 IS4 393012

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  59 reports
• Ilivia Neo 7 DR-T DF-1 ProMRI 429529

  DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
  1 death56 reports
• Sentus ProMRI OTW QP S-75/49 406081

  Drug eluting permanent left ventricular (lv) pacemaker electrode
  55 reports
• Solia T 53

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  54 reports
• Linox Smart S 60 375012

  Permanent defibrillator electrodes
  1 death53 reports
• Entovis DR-T ProMRI 371992

  Pulse generator, permanent, implantable
  52 reports
• Intica Neo 7 HF-T DF-1 IS-1 ProMRI 429553

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death51 reports
• Etrinsa 8 DR-T 394931

  Pulse generator, permanent, implantable
  50 reports
• Itrevia 7 VR-T DX DF-1 393037

  Implantable cardioverter defibrillator (non-CRT)
  49 reports
• Itrevia 7 DR-T DF4 392426

  DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
  1 death48 reports
• Ilivia 7 VR-T DF-1 ProMRI 404625

  Implantable cardioverter defibrillator (non-CRT)
  48 reports
• BIOTRONIK TrueLock

  Stimulator, spinal-cord, totally implanted for pain relief
  48 reports
• Selox ST 60 346367

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  1 death47 reports
• Lumax 740 DR-T 365606

  DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
  1 death47 reports
• Itrevia 7 VR-T DF4 393041

  Implantable cardioverter defibrillator (non-CRT)
  1 death44 reports
• Protego SD 60/16 399408

  Permanent defibrillator electrodes
  43 reports
• Corox OTW-S 75-BP

  Drug eluting permanent left ventricular (lv) pacemaker electrode
  42 reports
• Pamira S DX 65/17 428776

  Permanent defibrillator electrodes
  42 reports
• Rivacor 7 VR-T DF4 ProMRI 429536

  Implantable cardioverter defibrillator (non-CRT)
  42 reports
• Iperia 7 HF-T DF-1 ProMRI 393007

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  41 reports
• Ilesto 7 DR-T DF4 US 383564

  DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
  39 reports
• Corox OTW-S 85-BP

  Drug eluting permanent left ventricular (lv) pacemaker electrode
  36 reports
• Itrevia 7 DR-T DF-1 392412

  DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
  1 death36 reports
• Safio S 60 370946

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  35 reports
• Iperia 7 HF-T DF4 ProMRI 393009

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  35 reports
• Itrevia 7 HF-T QP DF4 IS4 401662

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 deaths34 reports
• Plexa S 60

  Permanent defibrillator electrodes
  33 reports
• Inventra 7 VR-T DX DF-1 399437

  Implantable cardioverter defibrillator (non-CRT)
  32 reports
• Plexa ProMRI DF-1 SD 65/18

  Permanent defibrillator electrodes
  32 reports