Study: NCT00281099

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 513 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 513 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 513 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 513 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 513 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 50 affected / 513 at risk

Adverse event: Congestive Heart Failure with Anemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 513 at risk

Adverse event: Congestive Heart Failure with Angina
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 513 at risk

Adverse event: Congestive Heart Failure with Atrial Fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 513 at risk

Adverse event: Congestive Heart Failure with Atrial Flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 513 at risk

Adverse event: Congestive Heart Failure with Bronchitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 513 at risk

Adverse event: Congestive Heart Failure with Chronic Obstructive Pulmonary Disease
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 513 at risk

Adverse event: Congestive Heart Failure with Coronary Artery Disease, SVT and VT
Serious: yes
Organ System: General disorders
Notes: Congestive Heart Failure with Coronary Artery Disease, Supraventricular Tachycardia (SVT) and Ventricular Tachycardia (VT)
Frequency: 1 affected / 513 at risk

Adverse event: Congestive Heart Failure with Infection - Respiratory Tract
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 513 at risk

Adverse event: Congestive Heart Failure with Myocardial Infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 513 at risk

Adverse event: Congestive Heart Failure with Pneumonia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 513 at risk

Adverse event: Congestive Heart Failure with Stroke
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 513 at risk

Adverse event: Congestive Heart Failure with Ventricular Fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 513 at risk

Adverse event: Congestive Heart Failure with Ventricular Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 513 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 513 at risk

Adverse event: Coronary Artery Disease with Ventricular Tachycardia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 513 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 513 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 513 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 513 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 513 at risk

Adverse event: Infection - Device, Leads
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 513 at risk

Adverse event: Infection - Pocket
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 513 at risk

Adverse event: Infection - Systemic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 513 at risk

Adverse event: Infection - Urinary Tract
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 513 at risk

Adverse event: Lead Fracture - Right Ventricular Lead
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 513 at risk

Adverse event: Leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 513 at risk

Adverse event: Leukemia - Myelogenous
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 513 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 513 at risk

Adverse event: Necrosis - Left Lower Extremity
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 513 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 513 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 513 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 513 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 513 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 513 at risk

Adverse event: Renal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 513 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 513 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 513 at risk

Adverse event: Sepsis
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 513 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 513 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 513 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 513 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 513 at risk

Adverse event: Ventricular Tachycardia and Ventricular Fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 513 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 36 affected / 513 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 55 affected / 513 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 25 affected / 513 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 518 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 518 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 518 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 518 at risk

Adverse event: Cerebellar haematoma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 518 at risk

Adverse event: Chronic Obstructive Pulmonary Disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 518 at risk

Adverse event: Chronic Obstructive Pulmonary Disorder with Renal Failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 518 at risk

Adverse event: Closed Head Trauma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 518 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 53 affected / 518 at risk

Adverse event: Congestive Heart Failure with Acute Respiratory Distress Syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 518 at risk

Adverse event: Congestive Heart Failure with Atrial Fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 518 at risk

Adverse event: Congestive Heart Failure with Atrial Flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 518 at risk

Adverse event: Congestive Heart Failure with Cellulitis and Anemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 518 at risk

Adverse event: Congestive Heart Failure with Coronary Artery Disease
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 518 at risk

Adverse event: Congestive Heart Failure with Coronary Artery Disease and Atrial Fibrillation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 518 at risk

Adverse event: Congestive Heart Failure with Myocardial Infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 518 at risk

Adverse event: Congestive Heart Failure with Myocardial Infarction and Renal Failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 518 at risk

Adverse event: Congestive Heart Failure with Pneumonia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 518 at risk

Adverse event: Congestive Heart Failure with Pneumonia and Renal Failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 518 at risk

Adverse event: Congestive Heart Failure with Pneumothorax and Right Atrial Lead Dislodgement
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 518 at risk

Adverse event: Congestive Heart Failure with Renal Failure
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 518 at risk

Adverse event: Congestive Heart Failure with Ventricular Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 518 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 518 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 518 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 518 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 518 at risk

Adverse event: Hypotension
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 518 at risk

Adverse event: Increased Right Ventricular Lead Impedance
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 518 at risk

Adverse event: Infection - Device, Leads
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 518 at risk

Adverse event: Infection - Incision Site
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 518 at risk

Adverse event: Infection - Pocket
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 518 at risk

Adverse event: Infection - Systemic
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 518 at risk

Adverse event: Infection - Urinary Tract
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 518 at risk

Adverse event: Lead Dislodgement - Right Ventricular Lead
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 518 at risk

Adverse event: Lead Fracture - Right Ventricular Lead
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 518 at risk

Adverse event: Lead Perforation - Right Ventricular Lead
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 518 at risk

Adverse event: Lead Protrusion - Right Ventricular Lead
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 518 at risk

Adverse event: Medication Allergy
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 518 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 518 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 518 at risk

Adverse event: Myocardial Infarction with Atrial Fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 518 at risk

Adverse event: Pantocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 518 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 518 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 518 at risk

Adverse event: Pleural Effusion with Renal Failure and Sepsis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 518 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 518 at risk

Adverse event: Pneumonia with Myocardial Infarction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 518 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 518 at risk

Adverse event: Device power source issue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 518 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 518 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 518 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 518 at risk

Adverse event: Respiratory Failure with Pneumonia and Atrial Fibrillation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 518 at risk

Adverse event: Sepsis
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 518 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 518 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 518 at risk

Adverse event: Ventricular Tachycardia and Ventricular Fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 518 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 43 affected / 518 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 44 affected / 518 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 26 affected / 518 at risk