Study: NCT00112125

Adverse event: General Cardiopulmonary Event
Serious: yes
Organ System: Cardiac disorders
Frequency: 46 affected / 212 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 25 affected / 212 at risk

Adverse event: General Medical
Serious: yes
Organ System: General disorders
Frequency: 54 affected / 212 at risk

Adverse event: ICD or Pacemaker System Malfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 212 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 29 affected / 212 at risk

Adverse event: Worsening Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 50 affected / 212 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 212 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 212 at risk

Adverse event: Neurologic Dysfunction
Serious: yes
Organ System: Nervous system disorders
Frequency: 12 affected / 212 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 212 at risk

Adverse event: General Cardiopulmonary Event
Serious: no
Organ System: Cardiac disorders
Frequency: 19 affected / 212 at risk

Adverse event: Arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 212 at risk

Adverse event: Worsening Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 29 affected / 212 at risk

Adverse event: Localised infection
Serious: no
Organ System: Infections and infestations
Frequency: 41 affected / 212 at risk

Adverse event: General Medical
Serious: no
Organ System: General disorders
Frequency: 86 affected / 212 at risk

Adverse event: General Cardiopulmonary Event
Serious: yes
Organ System: Cardiac disorders
Frequency: 42 affected / 210 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 29 affected / 210 at risk

Adverse event: General Medical
Serious: yes
Organ System: General disorders
Frequency: 63 affected / 210 at risk

Adverse event: ICD or Pacemaker System Malfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 210 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 27 affected / 210 at risk

Adverse event: Worsening Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 50 affected / 210 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 210 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 210 at risk

Adverse event: Neurologic Dysfunction
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 210 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 210 at risk

Adverse event: OPTIMIZER lead fracture
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 210 at risk

Adverse event: OPTIMIZER RV lead dislodgement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 6 affected / 210 at risk

Adverse event: IPG problem/change
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 210 at risk

Adverse event: OPTIMIZER RA lead dislodgement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 210 at risk

Adverse event: OPTIMIZER pocket dehiscence/erosion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 210 at risk

Adverse event: OPTIMIZER pocket infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 210 at risk

Adverse event: OPTIMIZER pocket stimulation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 210 at risk

Adverse event: Lead perforation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 210 at risk

Adverse event: OPTIMIZER pocket bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 210 at risk

Adverse event: Sensation due to CCM
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 210 at risk

Adverse event: Extracardiac stimulation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 210 at risk

Adverse event: General Cardiopulmonary Event
Serious: no
Organ System: Cardiac disorders
Frequency: 41 affected / 210 at risk

Adverse event: Arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 26 affected / 210 at risk

Adverse event: Worsening Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 32 affected / 210 at risk

Adverse event: Localised infection
Serious: no
Organ System: Infections and infestations
Frequency: 51 affected / 210 at risk

Adverse event: General Medical
Serious: no
Organ System: General disorders
Frequency: 105 affected / 210 at risk