Study: NCT01294449

Adverse event: Laboratory Values - Abnormal
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 149 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 149 at risk

Adverse event: Normal ERI -Device Replacement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 149 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 149 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 149 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 149 at risk

Adverse event: Endocrine
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 149 at risk

Adverse event: Erosion
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 149 at risk

Adverse event: Extracardiac Stimulation, Left Ventricular
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 149 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 149 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 149 at risk

Adverse event: Heart Failure Symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 23 affected / 149 at risk

Adverse event: Hypotention
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 149 at risk

Adverse event: Integumentary
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 149 at risk

Adverse event: Musculoskelatal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 149 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 149 at risk

Adverse event: Lead Related, Left Ventricular
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 149 at risk

Adverse event: Patient Condition - Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 149 at risk

Adverse event: Patient Condition - noncardiovascular
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 149 at risk

Adverse event: Device related, pulse generator
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 149 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 149 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 149 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 149 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 149 at risk

Adverse event: Systemic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 149 at risk

Adverse event: Thromboembolic
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 149 at risk

Adverse event: Vascular Related
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 149 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 149 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 149 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 149 at risk

Adverse event: Chest Pain - Non-Cardiac
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 149 at risk

Adverse event: Heart Failure Symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 149 at risk

Adverse event: Laboratory Values - Abnormal
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 245 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 245 at risk

Adverse event: Normal ERI -Device Replacement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 10 affected / 245 at risk

Adverse event: Chest Pain - Ischemic
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 245 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 245 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 245 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 245 at risk

Adverse event: ERI - device component failure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 245 at risk

Adverse event: Endocrine
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 245 at risk

Adverse event: Erosion
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 245 at risk

Adverse event: Extracardiac Stimulation, Left Ventricular
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 245 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 245 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 245 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 245 at risk

Adverse event: Head, Ears, Eyes, Nose and Throat
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 245 at risk

Adverse event: Heart Failure Symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 26 affected / 245 at risk

Adverse event: Hematological
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 245 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 245 at risk

Adverse event: Hypotention
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 245 at risk

Adverse event: Infection (> 30 days post implant procedure)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 245 at risk

Adverse event: Integumentary
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 245 at risk

Adverse event: Musculoskelatal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 245 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 245 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 245 at risk

Adverse event: Lead Related, Left Ventricular
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 245 at risk

Adverse event: Patient Condition - Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 245 at risk

Adverse event: Patient Condition - noncardiovascular
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 245 at risk

Adverse event: Device related, pulse generator
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 245 at risk

Adverse event: Physical Trauma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 245 at risk

Adverse event: Hemorrhage, pocket
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 245 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 245 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 245 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 245 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 245 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 245 at risk

Adverse event: Systemic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 245 at risk

Adverse event: Threshold Related, Left Ventricular
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 245 at risk

Adverse event: Thromboembolic
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 245 at risk

Adverse event: Valvular Related
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 245 at risk

Adverse event: Vascular Related
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 245 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 245 at risk

Adverse event: Chest Pain - Non-Cardiac
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 245 at risk

Adverse event: Ventricular extrasystoles
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 245 at risk

Adverse event: Heart Failure Symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 16 affected / 245 at risk