Study: NCT00180271

Adverse event: Lead Dislodgment, Left Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 46 affected / 1079 at risk

Adverse event: Lead Dislodgment, Right Atrial
Serious: yes
Organ System: Cardiac disorders
Frequency: 33 affected / 1079 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 15 affected / 1079 at risk

Adverse event: Hematoma, Pocket
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 14 affected / 1079 at risk

Adverse event: Extracardiac Stimulation, Left Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 1079 at risk

Adverse event: Lead Dislodgment, Right Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 1079 at risk

Adverse event: Thromboembolic Events
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 1079 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 6 affected / 1079 at risk

Adverse event: Adverse reaction
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 6 affected / 1079 at risk

Adverse event: Elevated Threshold, Right Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 1079 at risk

Adverse event: Infection, Post Surgical
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 9 affected / 1079 at risk

Adverse event: Inadvertent Ventricular Tachyarrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Arrhythmia inadvertently induced during implant procedure.
Frequency: 4 affected / 1079 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Surgical and medical procedures
Notes: Secondary to use of contrast media
Frequency: 4 affected / 1079 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 1079 at risk

Adverse event: Myocardial Perforation with Tamponade
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 1079 at risk

Adverse event: Elevated Defibrillation Thresholds
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 1079 at risk

Adverse event: Hemorrhage, Pocket
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1079 at risk

Adverse event: Inappropriate Tachyarrhythmia Therapy
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1079 at risk

Adverse event: Early Elective Replacement Indicator
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1079 at risk

Adverse event: Insulation Breach, Left Ventricular Lead
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1079 at risk

Adverse event: Inadvertent Supraventricular Tachyarrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1079 at risk

Adverse event: Arterial perforation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1079 at risk

Adverse event: Venous occlusion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1079 at risk

Adverse event: Seroma, Pocket
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1079 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1079 at risk

Adverse event: Worsening Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1079 at risk

Adverse event: Elevated Threshold, Left Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1079 at risk

Adverse event: Difficulty Measing Impedance/Amplitude
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1079 at risk

Adverse event: Pulse Generator Migration
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1079 at risk

Adverse event: Elevated Shock Impedance
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1079 at risk

Adverse event: Extrasystoles
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1079 at risk

Adverse event: Extracardiac Stimulation, Left Ventricular
Serious: no
Organ System: Cardiac disorders
Notes: Events corrected non-invasively with reprogramming.
Frequency: 70 affected / 1079 at risk

Adverse event: Pacemaker generated arrhythmia
Serious: no
Organ System: Cardiac disorders
Notes: Events corrected non-invasively with reprogramming.
Frequency: 56 affected / 1079 at risk

Adverse event: Lead Dislodgment, Left Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 712 at risk

Adverse event: Lead Dislodgment, Right Atrial
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 712 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 712 at risk

Adverse event: Hematoma, Pocket
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 712 at risk

Adverse event: Lead Dislodgment, Right Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 712 at risk

Adverse event: Thromboembolic Events
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 712 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 712 at risk

Adverse event: Adverse reaction
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 7 affected / 712 at risk

Adverse event: Elevated Threshold, Right Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 712 at risk

Adverse event: Infection, Post Surgical
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 712 at risk

Adverse event: Inadvertent Ventricular Tachyarrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Arrhythmia inadvertently induced during implant procedure.
Frequency: 2 affected / 712 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 712 at risk

Adverse event: Myocardial Perforation with Tamponade
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 712 at risk

Adverse event: Elevated Defibrillation Thresholds
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 712 at risk

Adverse event: Hemorrhage, Pocket
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 712 at risk

Adverse event: Inappropriate Tachyarrhythmia Therapy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 712 at risk

Adverse event: Early Elective Replacement Indicator
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 712 at risk

Adverse event: Worsening Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 712 at risk

Adverse event: Set Screws Not Tightened
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 712 at risk

Adverse event: Post Surgical Wound Discomfort
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 712 at risk