Study: NCT02577887

Adverse event: Loss of Normal Desired Pacing and/or Sensing due to Lead Displacement
Serious: yes
Organ System: Product Issues
Frequency: 25 affected / 2101 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 2101 at risk

Adverse event: Unknown Death
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 2101 at risk

Adverse event: Cardiac perforation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 2101 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 2101 at risk

Adverse event: Lead Malfunction
Serious: yes
Organ System: Product Issues
Notes: Fracture or damage to insulation
Frequency: 3 affected / 2101 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2101 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2101 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2101 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2101 at risk

Adverse event: Pacemaker generated arrhythmia
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 2101 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 2101 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2101 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2101 at risk

Adverse event: Inflammatory Allergic Reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 2101 at risk

Adverse event: Lead Misplacement
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2101 at risk

Adverse event: Loss of Normal Device Function due to Battery Failure or Component Malfunction
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 2101 at risk

Adverse event: Pericarditis associated with Dressler's Syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2101 at risk

Adverse event: Pocket erosion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2101 at risk

Adverse event: Reduction of LVEF due to RV Pacing
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 2101 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2101 at risk

Adverse event: Threshold Elevation
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 2101 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 2101 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 2101 at risk

Adverse event: Lead Noise
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 2101 at risk

Adverse event: Threshold Elevation
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 2101 at risk

Adverse event: Extracardiac Stimulation
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 2101 at risk

Adverse event: Pacemaker generated arrhythmia
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 2101 at risk

Adverse event: Pain at IPG Site
Serious: no
Organ System: General disorders
Frequency: 2 affected / 2101 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 2101 at risk