Study: NCT00610116

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 292 at risk

Adverse event: Multiple heart failure symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 292 at risk

Adverse event: Deep vein thrombosis (DVT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 292 at risk

Adverse event: Death (no details)
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 292 at risk

Adverse event: Cardiac vein dissection
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 292 at risk

Adverse event: Gastrointestinal disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 292 at risk

Adverse event: Inappropriate pulse generator Shock
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 292 at risk

Adverse event: Increase of Pacing Threshold
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 292 at risk

Adverse event: Ineffective Pulse Generator Shock
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 292 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 292 at risk

Adverse event: Lead Dislodgment
Serious: yes
Organ System: Product Issues
Frequency: 4 affected / 292 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 292 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 292 at risk

Adverse event: Pocket hematoma
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 292 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 292 at risk

Adverse event: Syncope - Non cardiovascular
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 292 at risk

Adverse event: Thoracic discomfort
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 292 at risk

Adverse event: Lead Replacement - Unknown reason
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 292 at risk

Adverse event: Intervention for Coronary Artery Disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 292 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 292 at risk

Adverse event: Death - Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 292 at risk

Adverse event: Death - Hemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 292 at risk

Adverse event: Death - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 292 at risk

Adverse event: Elevated Defibrillation Threshold
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 292 at risk

Adverse event: Device pacing issue
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 292 at risk

Adverse event: Extracardiac stimulation
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 292 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 292 at risk

Adverse event: Multiple heart failure symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 292 at risk

Adverse event: Immunotheraphy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 292 at risk

Adverse event: Arrhythmia supraventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 292 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 292 at risk

Adverse event: Contusion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 292 at risk

Adverse event: Cholecystomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 292 at risk

Adverse event: Cardiac vein dissection
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 292 at risk

Adverse event: Lead Dislodgment
Serious: no
Organ System: Product Issues
Frequency: 5 affected / 292 at risk

Adverse event: Pacing system infection
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 292 at risk

Adverse event: Pocket Hematoma
Serious: no
Organ System: Product Issues
Frequency: 5 affected / 292 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 292 at risk

Adverse event: Pulse Generator system issue
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 292 at risk

Adverse event: Lead - Procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 292 at risk