Study: NCT03103503

Adverse event: Haematoma
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 901 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 901 at risk

Adverse event: Loose set-screw
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 901 at risk

Adverse event: Non-healing pocket dehiscence requiring intervention
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 901 at risk

Adverse event: Cardiogenic shock during implantation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 901 at risk

Adverse event: Operation wound bleeding
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 901 at risk

Adverse event: Venous occlusion associated with the implant procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 901 at risk

Adverse event: LV lead related high pacing threshold
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 901 at risk

Adverse event: LV lead related lead dislodgement
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 901 at risk

Adverse event: Twiddler's syndrome
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 901 at risk

Adverse event: RV lead related lead dislodgement
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 901 at risk

Adverse event: RV lead related other: high defibrillation threshold.no evidence for lead malfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 901 at risk

Adverse event: RA lead related lead dislodgement
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 901 at risk

Adverse event: Pulmonary Emboli
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 901 at risk

Adverse event: RV lead related high pacing threshold
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 901 at risk

Adverse event: RV lead related intermittent capture
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 901 at risk

Adverse event: RV lead related lead impedance out of range, high
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 901 at risk

Adverse event: RV lead related lead undersensing
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 901 at risk

Adverse event: Haematoma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 901 at risk

Adverse event: Non-healing pocket dehiscence requiring intervention
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 901 at risk

Adverse event: Slow wound healing, no sign for infection
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 901 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 901 at risk

Adverse event: LV lead related extracardiac stimulation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 901 at risk

Adverse event: LV lead related lead impedance out of range, high
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 901 at risk

Adverse event: RV lead related lead dislodgement
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 901 at risk

Adverse event: RV lead related other: positional atrial undersensing
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 901 at risk

Adverse event: Skin erosion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 901 at risk

Adverse event: RA lead related lead dislodgement
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 901 at risk

Adverse event: RA lead related no capture
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 901 at risk