Study: NCT02809131

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Infection resulting from surgery or surgical procedure
Frequency: 5 affected / 505 at risk

Adverse event: Tenderness, erythema, or warmth at the pulse generator site
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 505 at risk

Adverse event: Purulent discharge
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 505 at risk

Adverse event: Vegetation adherent to CIED hardware
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 505 at risk

Adverse event: Allergic Reaction to pouch
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 505 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 505 at risk

Adverse event: Wound haematoma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 22 affected / 505 at risk

Adverse event: Lead dislodgement
Serious: no
Organ System: Surgical and medical procedures
Frequency: 6 affected / 505 at risk

Adverse event: Other device related complication
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 505 at risk

Adverse event: Other non device related complication
Serious: no
Organ System: General disorders
Frequency: 182 affected / 505 at risk

Adverse event: Heart transplant
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 505 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 505 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Infection resulting from surgery or surgical procedure
Frequency: 6 affected / 505 at risk

Adverse event: Tenderness, erythema, or warmth at the pulse generator site
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 505 at risk

Adverse event: Purulent discharge
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 505 at risk

Adverse event: Positive blood culture identifying a coagulase negative staphylococcus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 505 at risk

Adverse event: Vegetation adherent to CIED hardware
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 505 at risk

Adverse event: Purulent material within pulse generator pocket
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 505 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 505 at risk

Adverse event: Wound haematoma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 27 affected / 505 at risk

Adverse event: Lead dislodgement
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 505 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 505 at risk

Adverse event: Other device related complication
Serious: no
Organ System: Product Issues
Frequency: 12 affected / 505 at risk

Adverse event: Other non device related complication
Serious: no
Organ System: General disorders
Frequency: 149 affected / 505 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 505 at risk