Study: NCT00947310

Adverse event: Hematological
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 514 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 514 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 514 at risk

Adverse event: Thromboembolic events
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 514 at risk

Adverse event: Lead Dislodgment, Left Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 514 at risk

Adverse event: Threshold Related, Left Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 514 at risk

Adverse event: Pacemaker-mediated Tachycardia (PMT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 514 at risk

Adverse event: Premature Ventricular Contractions (PVC)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 514 at risk

Adverse event: Unable to Communicate with Pulse Generator
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 514 at risk

Adverse event: Lead Dislodgment, Right Atrial
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 514 at risk

Adverse event: Lead Related, Right Atrial
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 514 at risk

Adverse event: Sensing Related, Right Atrial
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 514 at risk

Adverse event: Lead Dislodgment, Right Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 514 at risk

Adverse event: Lead Related, Right Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 514 at risk

Adverse event: Sensing Related, Right Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 514 at risk

Adverse event: Threshold Related, Right Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 514 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 514 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 514 at risk

Adverse event: Chest Pain, Ischemic
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 514 at risk

Adverse event: Chest Pain, Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 514 at risk

Adverse event: Pulse Generator Erosion
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 514 at risk

Adverse event: Heart Failure Symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 84 affected / 514 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 514 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 514 at risk

Adverse event: Inappropriate Tachy Therapy
Serious: yes
Organ System: Cardiac disorders
Frequency: 14 affected / 514 at risk

Adverse event: Inadvertant Tachy Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 514 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 514 at risk

Adverse event: Cardiovascular, Patient Condition
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 514 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 514 at risk

Adverse event: Supraventricular Tachy Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 20 affected / 514 at risk

Adverse event: Valvular Related
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 514 at risk

Adverse event: Ventricular Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 26 affected / 514 at risk

Adverse event: Syncope, Cardiac Related
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 514 at risk

Adverse event: Endocrine Related
Serious: yes
Organ System: Endocrine disorders
Frequency: 4 affected / 514 at risk

Adverse event: Gastrointestinal Related
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 514 at risk

Adverse event: Abnormal Laboratory Value
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 514 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: This is not a complete listing of reported deaths, others are reported within other adverse event categories with a result in death.
Frequency: 1 affected / 514 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 514 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 514 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 514 at risk

Adverse event: Head, Eyes, Ears, Nose, Throat (HEENT)
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 514 at risk

Adverse event: Multi-System Failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 514 at risk

Adverse event: Related to Multiple Symptoms
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 514 at risk

Adverse event: Non-Cardiovascular, Patient Condition
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 514 at risk

Adverse event: Physical Trauma
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 514 at risk

Adverse event: Psychological
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 514 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 514 at risk

Adverse event: Syncope, General
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 514 at risk

Adverse event: Immune
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 514 at risk

Adverse event: Systemic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 514 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 514 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 514 at risk

Adverse event: Syncope, Neurological Related
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 514 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 10 affected / 514 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 14 affected / 514 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 514 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 514 at risk

Adverse event: Integumentary
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 514 at risk

Adverse event: Adverse Reaction, Implant Procedure Related
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 514 at risk

Adverse event: Bleeding, Implant Procedure Related
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 514 at risk

Adverse event: Hematoma, Pulse Generator Pocket (>30 days Post Device Implant)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 514 at risk

Adverse event: Infection, (> 30 days Post Device Implant)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 6 affected / 514 at risk

Adverse event: Pneumothorax, Procedure Related
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 514 at risk

Adverse event: Post Surgical Wound Discomfort
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 514 at risk

Adverse event: Post Surgical Infection (<= 30 days Post Device Implant)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 514 at risk

Adverse event: Post Surgical Pocket Hemorrhage
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 514 at risk

Adverse event: Venous occlusion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 514 at risk

Adverse event: Vascular Related
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 514 at risk

Adverse event: Extracardiac Stimulation, Left Ventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 32 affected / 514 at risk

Adverse event: Heart Failure Symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 34 affected / 514 at risk

Adverse event: Inappropriate Tachy Therapy
Serious: no
Organ System: Cardiac disorders
Frequency: 85 affected / 514 at risk

Adverse event: Supraventricular Tachy Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 30 affected / 514 at risk

Adverse event: Ventricular tachyarrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 26 affected / 514 at risk

Adverse event: Hematological
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 500 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 500 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Thromboembolic events
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 500 at risk

Adverse event: Extracardiac Stimulation, Left Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Lead Dislodgment, Left Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 500 at risk

Adverse event: Threshold Related, Left Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Lead Dislodgment, Right Atrial
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 500 at risk

Adverse event: Lead Dislodgment, Right Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 500 at risk

Adverse event: Lead Related, Right Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 500 at risk

Adverse event: Sensing Related, Right Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Threshold Related, Right Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 500 at risk

Adverse event: Chest Pain, Ischemic
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 500 at risk

Adverse event: Chest Pain, Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 500 at risk

Adverse event: Pulse Generator Erosion
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 500 at risk

Adverse event: Heart Failure Symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 67 affected / 500 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 500 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 500 at risk

Adverse event: Inappropriate Tachy Therapy
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 500 at risk

Adverse event: Inadvertant Tachy Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 500 at risk

Adverse event: Pulse Generator Migration
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 500 at risk

Adverse event: Cardiovascular, Patient Condition
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 500 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 500 at risk

Adverse event: Supraventricular Tachy Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 17 affected / 500 at risk

Adverse event: Ventricular Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 500 at risk

Adverse event: Syncope, Cardiac Related
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 500 at risk

Adverse event: Endocrine Related
Serious: yes
Organ System: Endocrine disorders
Frequency: 3 affected / 500 at risk

Adverse event: Gastrointestinal Related
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 500 at risk

Adverse event: Abnormal Laboratory Value
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 500 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: This is not a complete listing of reported deaths, others are reported within other adverse event categories with a result in death.
Frequency: 4 affected / 500 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 500 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 500 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 500 at risk

Adverse event: Head, Eyes, Ears, Nose, Throat (HEENT)
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 500 at risk

Adverse event: Multi-System Failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 500 at risk

Adverse event: Non-Cardiovascular, Patient Condition
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 500 at risk

Adverse event: Physical Trauma
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 500 at risk

Adverse event: Psychological
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 500 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 500 at risk

Adverse event: Syncope, General
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 500 at risk

Adverse event: Systemic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 500 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 500 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 500 at risk

Adverse event: Syncope, Neurological Related
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 500 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 500 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 500 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 500 at risk

Adverse event: Integumentary
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 500 at risk

Adverse event: Seroma, Pocket (<= 30 days Post Pulse Generator Implant)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 500 at risk

Adverse event: Adverse Reaction, Implant Procedure Related
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 500 at risk

Adverse event: Bleeding, Implant Procedure Related
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 500 at risk

Adverse event: Infection, (> 30 days Post Device Implant)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 500 at risk

Adverse event: Pneumothorax, Procedure Related
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 500 at risk

Adverse event: Post Surgical Wound Discomfort
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 500 at risk

Adverse event: Post Surgical Infection (<= 30 days Post Device Implant)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 500 at risk

Adverse event: Vascular Related
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 500 at risk

Adverse event: Extracardiac Stimulation, Left Ventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 26 affected / 500 at risk

Adverse event: Heart Failure Symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 32 affected / 500 at risk

Adverse event: Pacemaker-mediated Tachycardia (PMT)
Serious: no
Organ System: Cardiac disorders
Frequency: 29 affected / 500 at risk

Adverse event: Supraventricular Tachy Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 29 affected / 500 at risk

Adverse event: Ventricular tachyarrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 20 affected / 500 at risk

Adverse event: Hematological
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 486 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 486 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 486 at risk

Adverse event: Thromboembolic events
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 486 at risk

Adverse event: Extracardiac Stimulation, Left Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 486 at risk

Adverse event: Lead Dislodgment, Left Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 486 at risk

Adverse event: Threshold Related, Left Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 486 at risk

Adverse event: Pulse Generator-System, Patient-Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 486 at risk

Adverse event: Pacemaker-mediated Tachycardia (PMT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 486 at risk

Adverse event: Premature Ventricular Contractions (PVC)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 486 at risk

Adverse event: Elevated Threshold, Right Atrial
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 486 at risk

Adverse event: Lead Dislodgment, Right Atrial
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 486 at risk

Adverse event: Lead Dislodgment, Right Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 486 at risk

Adverse event: Sensing Related, Right Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 486 at risk

Adverse event: Threshold Related, Right Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 486 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 486 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 486 at risk

Adverse event: Chest Pain, Ischemic
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 486 at risk

Adverse event: Chest Pain, Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 17 affected / 486 at risk

Adverse event: Pulse Generator Erosion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 486 at risk

Adverse event: Heart Failure Symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 80 affected / 486 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 486 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 486 at risk

Adverse event: Inappropriate Tachy Therapy
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 486 at risk

Adverse event: Inadvertant Tachy Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 486 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 486 at risk

Adverse event: Cardiovascular, Patient Condition
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 486 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 486 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 486 at risk

Adverse event: Supraventricular Tachy Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 22 affected / 486 at risk

Adverse event: Valvular Related
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 486 at risk

Adverse event: Ventricular Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 486 at risk

Adverse event: Syncope, Cardiac Related
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 486 at risk

Adverse event: Endocrine Related
Serious: yes
Organ System: Endocrine disorders
Frequency: 5 affected / 486 at risk

Adverse event: Gastrointestinal Related
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 486 at risk

Adverse event: Abnormal Laboratory Value
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 486 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: This is not a complete listing of reported deaths, others are reported within other adverse event categories with a result in death.
Frequency: 4 affected / 486 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 486 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 486 at risk

Adverse event: Head, Eyes, Ears, Nose, Throat (HEENT)
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 486 at risk

Adverse event: Multi-System Failure
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 486 at risk

Adverse event: Related to Multiple Symptoms
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 486 at risk

Adverse event: Non-Cardiovascular, Patient Condition
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 486 at risk

Adverse event: Physical Trauma
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 486 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 486 at risk

Adverse event: Syncope, General
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 486 at risk

Adverse event: Systemic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 486 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 486 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 486 at risk

Adverse event: Syncope, Neurological Related
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 486 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 486 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 486 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 486 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 486 at risk

Adverse event: Integumentary
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 486 at risk

Adverse event: Myocardial Perforation, Post-Implant, Right Ventricular
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 486 at risk

Adverse event: Bleeding, Implant Procedure Related
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 486 at risk

Adverse event: Coronary Venous Trauma
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 486 at risk

Adverse event: Infection, (> 30 days Post Device Implant)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 486 at risk

Adverse event: Pneumothorax, Procedure Related
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 486 at risk

Adverse event: Post Surgical Wound Discomfort
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 486 at risk

Adverse event: Post Surgical Infection (<= 30 days Post Device Implant)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 486 at risk

Adverse event: Venous occlusion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 486 at risk

Adverse event: Vascular Related
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 486 at risk

Adverse event: Extracardiac Stimulation, Left Ventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 24 affected / 486 at risk

Adverse event: Heart Failure Symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 35 affected / 486 at risk

Adverse event: Inappropriate Tachy Therapy
Serious: no
Organ System: Cardiac disorders
Frequency: 20 affected / 486 at risk

Adverse event: Pacemaker-mediated Tachycardia (PMT)
Serious: no
Organ System: Cardiac disorders
Frequency: 20 affected / 486 at risk

Adverse event: Supraventricular Tachy Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 22 affected / 486 at risk