Study: NCT00412607

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 233 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 233 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 233 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 233 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 233 at risk

Adverse event: Coronary Artery Disease Intervention
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 233 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 233 at risk

Adverse event: Pulseless Electrical Activity at Device Site
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 233 at risk

Adverse event: Staphylococcus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 233 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 233 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 233 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 233 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 233 at risk

Adverse event: Urinary Tract Infection/Urinary Retention Retention
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 233 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 233 at risk

Adverse event: AV Fistula
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 233 at risk

Adverse event: Aortoiliac Dissection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 233 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 233 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 233 at risk

Adverse event: Hemodynamically Unstable
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 233 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 233 at risk

Adverse event: Tamponade
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 233 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 233 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 233 at risk

Adverse event: Adult Respiratory Failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 233 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 233 at risk

Adverse event: Atrioventricular node ablation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 233 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 233 at risk

Adverse event: Arrhythmia - Not Elsewhere Classified
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 233 at risk

Adverse event: Atrial tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 233 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 22 affected / 233 at risk

Adverse event: Biventricular assist device placed
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 233 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 233 at risk

Adverse event: Cardiac - Not Elsewhere Classified
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 233 at risk

Adverse event: Cardiac arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 233 at risk

Adverse event: Cardiac stents
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 233 at risk

Adverse event: Chest Pain - Not Elsewhere Classified
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 233 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 50 affected / 233 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 233 at risk

Adverse event: Endocarditis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 233 at risk

Adverse event: Atrioventricular block
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 233 at risk

Adverse event: Heart transplant
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 233 at risk

Adverse event: Implantable Cardioverter Defibrillator maintenance
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 233 at risk

Adverse event: Implantable Cardioverter Defibrillator shock - Not Elsewhere Classified
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 233 at risk

Adverse event: Mitral valve regurgitation
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 233 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 233 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 233 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 233 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 233 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 68 affected / 233 at risk

Adverse event: Abdominal pain - Not Elsewhere Classified
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 233 at risk

Adverse event: Appendicitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 233 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 233 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 233 at risk

Adverse event: Oesophageal carcinoma
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 233 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 233 at risk

Adverse event: Ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 233 at risk

Adverse event: Chest Pain - Not Elsewhere Classified
Serious: no
Organ System: General disorders
Frequency: 5 affected / 233 at risk

Adverse event: Chest Pain - Non cardiac
Serious: no
Organ System: General disorders
Frequency: 6 affected / 233 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 233 at risk

Adverse event: Elective - Dental
Serious: no
Organ System: General disorders
Frequency: 1 affected / 233 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 233 at risk

Adverse event: Pain - Not Elsewhere Classified
Serious: no
Organ System: General disorders
Frequency: 1 affected / 233 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 233 at risk

Adverse event: Bacteraemia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 233 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 233 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 233 at risk

Adverse event: Gangrene
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 233 at risk

Adverse event: Infection - Not Elsewhere Classified
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 233 at risk

Adverse event: Knee infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 233 at risk

Adverse event: Methicillin-resistant Staphylococcus aureus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 233 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 233 at risk

Adverse event: Prostatitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 233 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 233 at risk

Adverse event: Urinary Tract Infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 233 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 233 at risk

Adverse event: Arteriovenous fistula
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 233 at risk

Adverse event: Cardiac - Not Elsewhere Classified
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 233 at risk

Adverse event: Fracture - Fibula
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 233 at risk

Adverse event: Fracture - hip
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 233 at risk

Adverse event: Fracture - jaw
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 233 at risk

Adverse event: Fracture - pelvis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 233 at risk

Adverse event: Fracture - rib
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 233 at risk

Adverse event: Fracture - wrist
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 233 at risk

Adverse event: Haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 233 at risk

Adverse event: Vascular pseudoaneurysm
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 233 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 233 at risk

Adverse event: Wound - Not Elsewhere Classified
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 233 at risk

Adverse event: Death
Serious: no
Organ System: Investigations
Frequency: 12 affected / 233 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 233 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 233 at risk

Adverse event: Gastrointestinal carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 233 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 233 at risk

Adverse event: Lung neoplasm malignant
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 233 at risk

Adverse event: Cysts
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 233 at risk

Adverse event: Pancreatic carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 233 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 233 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 233 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 233 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 233 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 233 at risk

Adverse event: Vertigo
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 233 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 233 at risk

Adverse event: Schizophrenia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 233 at risk

Adverse event: Renal - Not Elsewhere Classified
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 233 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 233 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 233 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 233 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 233 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 233 at risk

Adverse event: Diaphragmatic paralysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 233 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 233 at risk

Adverse event: Oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 233 at risk

Adverse event: Epitaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 233 at risk

Adverse event: Fibrosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 233 at risk

Adverse event: Aortic aneurysm
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 233 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 233 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 233 at risk

Adverse event: Revascularization
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 233 at risk

Adverse event: Chest Pain - Not Elsewhere Classified
Serious: no
Organ System: General disorders
Frequency: 1 affected / 233 at risk

Adverse event: Transplant - Not Elsewhere Classified
Serious: no
Organ System: Investigations
Frequency: 1 affected / 233 at risk

Adverse event: Nodule
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 233 at risk