Study: NCT01791127

Adverse event: Accumulation of serous fluid in pocket
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1758 at risk

Adverse event: Cardiac perforation associated with the RA lead
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1758 at risk

Adverse event: Cardiac perforation associated with the RV lead
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1758 at risk

Adverse event: Cardiac perforation associated with the Siello lead
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1758 at risk

Adverse event: Inability to place RA lead
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1758 at risk

Adverse event: Lead related thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1758 at risk

Adverse event: LV lead related extracardiac stimulation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1758 at risk

Adverse event: LV lead related lead dislodgement
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1758 at risk

Adverse event: Pulse generator failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1758 at risk

Adverse event: Pulse generator migration
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1758 at risk

Adverse event: RA lead related (non-Siello) lead dislodgement
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1758 at risk

Adverse event: RA lead related high pacing threshold
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1758 at risk

Adverse event: RA lead related lead dislodgement
Serious: yes
Organ System: Cardiac disorders
Frequency: 39 affected / 1758 at risk

Adverse event: RA lead suspected lead failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1758 at risk

Adverse event: RA lead undersensing or loss of sensing
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1758 at risk

Adverse event: RV lead conductor fracture
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1758 at risk

Adverse event: RV lead impedance out of range, high impedance
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1758 at risk

Adverse event: RV lead intermittent capture, no lead capture
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1758 at risk

Adverse event: RV lead lead insulation failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1758 at risk

Adverse event: RV lead related (non-Siello) lead dislodgement
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1758 at risk

Adverse event: RV lead related extracardiac stimulation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1758 at risk

Adverse event: RV lead related high pacing threshold
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1758 at risk

Adverse event: RV lead related lead dislodgement
Serious: yes
Organ System: Cardiac disorders
Frequency: 22 affected / 1758 at risk

Adverse event: Software malfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1758 at risk

Adverse event: Twiddler's syndrome
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 1758 at risk

Adverse event: Implant procedure related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 1758 at risk

Adverse event: Prosthetic aortic valve endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1758 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1758 at risk

Adverse event: Skin erosion
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1758 at risk

Adverse event: Cardiac perforation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1758 at risk

Adverse event: Damage to lead during procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 6 affected / 1758 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 9 affected / 1758 at risk

Adverse event: Lead dislodgement during a procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 1758 at risk

Adverse event: Lead reversed in header
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1758 at risk

Adverse event: Loose set-screw
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 6 affected / 1758 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 8 affected / 1758 at risk

Adverse event: Pocket pain
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 6 affected / 1758 at risk

Adverse event: Possible transient ischemic attack
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1758 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1758 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1758 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1758 at risk

Adverse event: Venous occlusion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 1758 at risk

Adverse event: Atrial oversensing
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1758 at risk

Adverse event: Cardiac perforation associated with the LV lead
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1758 at risk

Adverse event: Cardiac perforation associated with the RV lead
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1758 at risk

Adverse event: Cardiac perforation associated with the Siello lead
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1758 at risk

Adverse event: Failure of fixation helix to retract
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1758 at risk

Adverse event: Inability to place LV lead
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1758 at risk

Adverse event: LV lead impedance out of range, high impedance
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1758 at risk

Adverse event: LV lead intermittent capture, no lead capture
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1758 at risk

Adverse event: LV lead related diaphragmatic stimulation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1758 at risk

Adverse event: LV lead related extracardiac stimulation
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 1758 at risk

Adverse event: LV lead related high pacing threshold
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 1758 at risk

Adverse event: LV lead related lead dislodgement
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1758 at risk

Adverse event: LV lead related oversensing
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1758 at risk

Adverse event: RA lead (non-Siello) undersensing or loss of sensing
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1758 at risk

Adverse event: RA lead intermittent capture, no lead capture
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1758 at risk

Adverse event: RA lead related (non-Siello) high pacing threshold
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1758 at risk

Adverse event: RA lead related extracardiac stimulation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1758 at risk

Adverse event: RA lead related high pacing threshold
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 1758 at risk

Adverse event: RA lead related lead dislodgement
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1758 at risk

Adverse event: RA lead undersensing or loss of sensing
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 1758 at risk

Adverse event: RV lead impedance out of range, high impedance
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1758 at risk

Adverse event: RV lead related (non-Siello) high pacing threshold
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1758 at risk

Adverse event: RV lead related extracardiac stimulation
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1758 at risk

Adverse event: RV lead related high pacing threshold
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 1758 at risk

Adverse event: RV lead related lead dislodgement
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1758 at risk

Adverse event: RV lead undersensing or loss of sensing
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 1758 at risk

Adverse event: Transient inhibition secondary to EMI
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1758 at risk

Adverse event: Implant procedure related infection
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 1758 at risk

Adverse event: Allergic reaction at pocket site
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1758 at risk

Adverse event: Damage to lead during procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1758 at risk

Adverse event: Haematoma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 30 affected / 1758 at risk

Adverse event: Inability to place LV lead
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1758 at risk

Adverse event: Inability to place RA lead
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1758 at risk

Adverse event: Inability to place RV lead
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1758 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1758 at risk

Adverse event: Pericarditis
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1758 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1758 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1758 at risk

Adverse event: Pocket pain
Serious: no
Organ System: Surgical and medical procedures
Frequency: 7 affected / 1758 at risk

Adverse event: RA lead dislodgement during a procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1758 at risk

Adverse event: Venous occlusion
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1758 at risk