Study: NCT00418314

Adverse event: Angiocardiogram
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 816 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 816 at risk

Adverse event: Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 816 at risk

Adverse event: Cardiac perforation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 816 at risk

Adverse event: Chest pain/MI
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 816 at risk

Adverse event: Cardiac vein dissection
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 816 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 816 at risk

Adverse event: Elevated Pacing Thresholds
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 816 at risk

Adverse event: Erosion/Pocket Pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 816 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 816 at risk

Adverse event: Infection
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 816 at risk

Adverse event: Lead Dislodgment/Migration
Serious: yes
Organ System: Cardiac disorders
Frequency: 40 affected / 816 at risk

Adverse event: Lead Fracture/Insulation Damage
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 816 at risk

Adverse event: Oversensing/Undersensing
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 816 at risk

Adverse event: Phrenic Nerve/Diaphragmatic Nerve Stimulation
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 816 at risk

Adverse event: Other cardiac
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 816 at risk

Adverse event: Endocrine disorders
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 816 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 816 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 816 at risk

Adverse event: CVA/TIA
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 816 at risk

Adverse event: Neurologic other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 816 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 816 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 816 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 816 at risk

Adverse event: Respiratory other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 816 at risk

Adverse event: Cardio-respiratory arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 816 at risk

Adverse event: Arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 65 affected / 816 at risk

Adverse event: Elevated Pacing Thresholds
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 816 at risk

Adverse event: Undersensing/Oversensing
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 816 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 61 affected / 816 at risk

Adverse event: Haematoma
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 816 at risk

Adverse event: Infection
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 816 at risk

Adverse event: Lead Dislodgement/Migration
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 816 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 816 at risk

Adverse event: Phrenic Nerve/Diaphragmatic Nerve Stimulation
Serious: no
Organ System: Cardiac disorders
Frequency: 36 affected / 816 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 816 at risk

Adverse event: Therapy for non-ventricular rhythm
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 816 at risk

Adverse event: Angiocardiogram
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 828 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 828 at risk

Adverse event: Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 828 at risk

Adverse event: Cardiac perforation
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 828 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 828 at risk

Adverse event: Chest pain/MI
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 828 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 828 at risk

Adverse event: Device migration/malfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 828 at risk

Adverse event: Elevated Pacing Thresholds
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 828 at risk

Adverse event: Erosion/Pocket Pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 828 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 828 at risk

Adverse event: Infection
Serious: yes
Organ System: Cardiac disorders
Frequency: 14 affected / 828 at risk

Adverse event: Lead Dislodgment/Migration
Serious: yes
Organ System: Cardiac disorders
Frequency: 35 affected / 828 at risk

Adverse event: Oversensing/Undersensing
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 828 at risk

Adverse event: Phrenic Nerve/Diaphragmatic Nerve Stimulation
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 828 at risk

Adverse event: Therapy for non-ventricular rhythm
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 828 at risk

Adverse event: Valve replacement
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 828 at risk

Adverse event: Other cardiac
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 828 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 828 at risk

Adverse event: CVA/TIA
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 828 at risk

Adverse event: Neurologic other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 828 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 828 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 828 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 828 at risk

Adverse event: Respiratory other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 828 at risk

Adverse event: Cardio-respiratory arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 828 at risk

Adverse event: Arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 55 affected / 828 at risk

Adverse event: Elevated Pacing Thresholds
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 828 at risk

Adverse event: Undersensing/Oversensing
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 828 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 43 affected / 828 at risk

Adverse event: Haematoma
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 828 at risk

Adverse event: Infection
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 828 at risk

Adverse event: Lead Dislodgement/Migration
Serious: no
Organ System: Cardiac disorders
Frequency: 17 affected / 828 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 828 at risk

Adverse event: Phrenic Nerve/Diaphragmatic Nerve Stimulation
Serious: no
Organ System: Cardiac disorders
Frequency: 30 affected / 828 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 828 at risk

Adverse event: Therapy for non-ventricular rhythm
Serious: no
Organ System: Cardiac disorders
Frequency: 16 affected / 828 at risk