Study: NCT01510652

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 53 affected / 719 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 719 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 719 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 41 affected / 719 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 16 affected / 719 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 24 affected / 719 at risk

Adverse event: Lead Dislodgement (LV Lead)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 37 affected / 719 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 719 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 719 at risk

Adverse event: Phrenic Nerve Stimulation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 719 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 719 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 719 at risk

Adverse event: Other - Non Cardiac
Serious: yes
Organ System: General disorders
Frequency: 81 affected / 719 at risk

Adverse event: Other - Cardiac
Serious: yes
Organ System: Cardiac disorders
Frequency: 20 affected / 719 at risk

Adverse event: Cardiac Perforation (RV Lead)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 719 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 719 at risk

Adverse event: Death for Unknown Causes
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 719 at risk

Adverse event: Pocket erosion
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 719 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 719 at risk

Adverse event: Lead Dislodgement (RA Lead)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 7 affected / 719 at risk

Adverse event: Lead Dislodgement (RV Lead)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 15 affected / 719 at risk

Adverse event: Lead Fracture (RV Lead)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 719 at risk

Adverse event: Lead Malfunction (RA Lead)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 719 at risk

Adverse event: Lead Unstable Position (LV Lead)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 719 at risk

Adverse event: Loss of Capture (RV Lead)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 719 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 28 affected / 719 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 719 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 719 at risk

Adverse event: Haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 25 affected / 719 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 719 at risk

Adverse event: Lead Damaged during Implant
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 719 at risk

Adverse event: Lead Dislodgement (LV Lead)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 7 affected / 719 at risk

Adverse event: Phrenic Nerve stimulation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 719 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 719 at risk

Adverse event: Other - Non Cardiac
Serious: no
Organ System: General disorders
Frequency: 42 affected / 719 at risk

Adverse event: Cardiac Perforation (Other Device Related)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 719 at risk

Adverse event: Other - Cardiac
Serious: no
Organ System: Cardiac disorders
Frequency: 19 affected / 719 at risk

Adverse event: Coronary Sinus Dissection (LV Lead Related)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 719 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 719 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 719 at risk

Adverse event: Coronary Sinus Dissection (Other Device Related)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 6 affected / 719 at risk

Adverse event: High Voltage Lead Impedance (RV Lead)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 719 at risk

Adverse event: Lead Dislodgement (RA Lead)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 719 at risk

Adverse event: Loss Of Capture (LV Lead)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 719 at risk

Adverse event: Oversensing (RV Lead)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 719 at risk

Adverse event: Pacing Impedance Out Of Range (LV Lead)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 719 at risk

Adverse event: Pacing Impedance Out Of Range (RV Lead)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 719 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 35 affected / 355 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 355 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 355 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 24 affected / 355 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 355 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 22 affected / 355 at risk

Adverse event: Lead Dislodgement (LV Lead)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 20 affected / 355 at risk

Adverse event: Lead Fracture (LV Lead)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 355 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 355 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 355 at risk

Adverse event: Phrenic Nerve Stimulation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 355 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 355 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 355 at risk

Adverse event: Other - Non Cardiac
Serious: yes
Organ System: General disorders
Frequency: 48 affected / 355 at risk

Adverse event: Other - Cardiac
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 355 at risk

Adverse event: Cardiac Perforation (RV Lead)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 355 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 355 at risk

Adverse event: Coronary Sinus Dissection (LV Lead related)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 355 at risk

Adverse event: Death for Unknown Causes
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 355 at risk

Adverse event: Pocket erosion
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 355 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 355 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 355 at risk

Adverse event: Coronary Sinus Dissection (Other Device related)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 355 at risk

Adverse event: Lead Dislodgement (RA Lead)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 355 at risk

Adverse event: Lead Dislodgement (RV Lead)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 355 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 355 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 355 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 355 at risk

Adverse event: Haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 355 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 355 at risk

Adverse event: Lead Dislodgement (LV Lead)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 355 at risk

Adverse event: Phrenic Nerve stimulation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 355 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 355 at risk

Adverse event: Other - Non Cardiac
Serious: no
Organ System: General disorders
Frequency: 16 affected / 355 at risk

Adverse event: Other - Cardiac
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 355 at risk

Adverse event: Coronary Sinus Dissection (Other Device Related)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 355 at risk

Adverse event: Lead Dislodgement (RA Lead)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 355 at risk