Study: NCT02243696

Adverse event: Atrial lead conductor fracture
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1694 at risk

Adverse event: Atrial lead dislodgement
Serious: yes
Organ System: Cardiac disorders
Frequency: 21 affected / 1694 at risk

Adverse event: Atrial lead high pacing threshold
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1694 at risk

Adverse event: Cardiac perforation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1694 at risk

Adverse event: Inability to defibrillate successfully with the Protego lead
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1694 at risk

Adverse event: LV lead diaphragmatic stimulation
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1694 at risk

Adverse event: LV lead dislodgement
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 1694 at risk

Adverse event: LV lead high pacing threshold
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1694 at risk

Adverse event: LV lead impedance out of range, high impedance
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1694 at risk

Adverse event: LV lead intermittent capture / no lead capture
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1694 at risk

Adverse event: Device power source issue
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1694 at risk

Adverse event: Pulse generator failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1694 at risk

Adverse event: Pulse generator migration
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1694 at risk

Adverse event: RV lead conductor fracture
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 1694 at risk

Adverse event: RV lead dislodgement
Serious: yes
Organ System: Cardiac disorders
Frequency: 26 affected / 1694 at risk

Adverse event: RV lead failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1694 at risk

Adverse event: RV lead high pacing threshold
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1694 at risk

Adverse event: RV lead impedance out of range, high impedance
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1694 at risk

Adverse event: RV lead impedance out of range, low impedance
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1694 at risk

Adverse event: RV lead intermittent capture / no lead capture
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1694 at risk

Adverse event: RV lead oversensing not due to external noise
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 1694 at risk

Adverse event: RV lead undersensing or loss of sensing
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1694 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1694 at risk

Adverse event: Twiddler's syndrome
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1694 at risk

Adverse event: Primary infection
Serious: yes
Organ System: Infections and infestations
Frequency: 21 affected / 1694 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 1694 at risk

Adverse event: Skin erosion
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1694 at risk

Adverse event: Cardiac perforation with or without tamponade
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1694 at risk

Adverse event: Cardiac vein dissection
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1694 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 9 affected / 1694 at risk

Adverse event: Loose set-screw
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1694 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 1694 at risk

Adverse event: Pocket pain
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1694 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1694 at risk

Adverse event: Venous occlusion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1694 at risk

Adverse event: Atrial lead dislodgement
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 1694 at risk

Adverse event: Atrial lead high pacing threshold
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 1694 at risk

Adverse event: Atrial lead impedance out of range, high impedance
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1694 at risk

Adverse event: Atrial lead impedance out of range, low impedance
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1694 at risk

Adverse event: Atrial lead intermittent capture / no lead capture
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1694 at risk

Adverse event: Bent connector pin noted during implant procedure
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1694 at risk

Adverse event: Inability to extend helix during implant procedure
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1694 at risk

Adverse event: Inability to successfully implant Protego lead
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1694 at risk

Adverse event: LV lead diaphragmatic stimulation
Serious: no
Organ System: Cardiac disorders
Frequency: 31 affected / 1694 at risk

Adverse event: LV lead dislodgement
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1694 at risk

Adverse event: LV lead high pacing threshold
Serious: no
Organ System: Cardiac disorders
Frequency: 59 affected / 1694 at risk

Adverse event: LV lead impedance out of range, high impedance
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1694 at risk

Adverse event: LV lead intermittent capture / no lead capture
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 1694 at risk

Adverse event: LV lead oversensing not due to external noise
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1694 at risk

Adverse event: Pulse generator back-up mode initiated
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 1694 at risk

Adverse event: RV lead diaphragmatic stimulation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1694 at risk

Adverse event: RV lead high pacing threshold
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 1694 at risk

Adverse event: RV lead impedance out of range, high impedance
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1694 at risk

Adverse event: RV lead impedance out of range, low impedance
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1694 at risk

Adverse event: RV lead intermittent capture / no lead capture
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1694 at risk

Adverse event: RV lead oversensing not due to external noise
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1694 at risk

Adverse event: RV lead undersensing or loss of sensing
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1694 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 1694 at risk

Adverse event: Skin erosion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1694 at risk

Adverse event: Damage to lead during procedure (e.g. accidental cut to lead body during pocket revision, device rep
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1694 at risk

Adverse event: Haematoma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 1694 at risk

Adverse event: Inability to successfully implant Protego lead due to patient anatomy
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1694 at risk

Adverse event: Pocket pain
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1694 at risk

Adverse event: RA lead dislodgement during a procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1694 at risk

Adverse event: RV lead dislodgement during a procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1694 at risk

Adverse event: Venous occlusion
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1694 at risk

Adverse event: Venous thrombosis without pulmonary embolism
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1694 at risk