Study: NCT00955708

Adverse event: Extracardiac Stimulation, Left Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 1303 at risk

Adverse event: Lead Dislodgment, Left Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 29 affected / 1303 at risk

Adverse event: Threshold Related, Left Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 19 affected / 1303 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1303 at risk

Adverse event: Cardiac Vessel Dissection
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1303 at risk

Adverse event: Lead Revision for no heart failure improvement, Left Ventricular
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1303 at risk

Adverse event: Accelerated Ventricular Rhythm
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1303 at risk

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1303 at risk

Adverse event: Pulse Generator Possible Malfunction
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 1303 at risk

Adverse event: Pulse Generator Related
Serious: yes
Organ System: Surgical and medical procedures
Notes: Lead to device connection re-evaluated
Frequency: 1 affected / 1303 at risk

Adverse event: Erosion/Migration
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 9 affected / 1303 at risk

Adverse event: Heart Failure Decompensation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1303 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1303 at risk

Adverse event: Inability to provide therapy, pulse generator
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 1303 at risk

Adverse event: Infection, Procedure related
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 10 affected / 1303 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1303 at risk

Adverse event: Premature Ventricular Contractions (PVCs)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1303 at risk

Adverse event: Impedance Related, Atrial Lead
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1303 at risk

Adverse event: Infection, Atrial Lead
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1303 at risk

Adverse event: Lead Dislodgment, Atrial Lead
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 1303 at risk

Adverse event: Sensing Related, Atrial Lead
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1303 at risk

Adverse event: Threshold Related, Atrial Lead
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1303 at risk

Adverse event: Cardiac Perforation, Right Ventricular
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1303 at risk

Adverse event: Impedance Related, Right Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1303 at risk

Adverse event: Inappropriate Tachy Therapy, Right Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1303 at risk

Adverse event: Infection, Right Ventricular
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1303 at risk

Adverse event: Lead Dislodgment, Right Ventricular
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 1303 at risk

Adverse event: Pneumothorax, Right Ventricular
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1303 at risk

Adverse event: Sensing Related, Right Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1303 at risk

Adverse event: Threshold Related, Right Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1303 at risk

Adverse event: Extracardiac Stimulation, Left Ventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 77 affected / 1303 at risk

Adverse event: Threshold Related, Left Ventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 26 affected / 1303 at risk

Adverse event: Inappropriate Tachy Therapy, Pulse Generator
Serious: no
Organ System: Cardiac disorders
Frequency: 28 affected / 1303 at risk