Study: NCT01463358

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 49 at risk

Adverse event: atrio-ventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 49 at risk

Adverse event: symptomatic bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 49 at risk

Adverse event: Heart Failure exhacerbation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 49 at risk

Adverse event: intervention for coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Notes: Coronary artery Bypass Graft or Percutaneous angioplasty
Frequency: 2 affected / 49 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 49 at risk

Adverse event: Loss of pacemaker capture
Serious: yes
Organ System: Product Issues
Notes: requiring invasive system revision
Frequency: 3 affected / 49 at risk

Adverse event: Pacing lead dislodgment
Serious: yes
Organ System: Product Issues
Notes: requiring invasive system revision
Frequency: 1 affected / 49 at risk

Adverse event: Pacemaker system infection
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 49 at risk

Adverse event: Musculoskeletal trauma
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 49 at risk

Adverse event: Urinary disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 49 at risk

Adverse event: Neoplasm
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 49 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Notes: non-serious: treated with variation to medical therapy
Frequency: 5 affected / 49 at risk

Adverse event: pacemaker signal oversensing/undersensing
Serious: no
Organ System: Product Issues
Notes: non serious: resolved with pacemaker reprogramming
Frequency: 6 affected / 49 at risk

Adverse event: pacemaker: rise in pacing threshold
Serious: no
Organ System: Product Issues
Notes: non serious: resolved with pacemaker reprogramming
Frequency: 2 affected / 49 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 52 at risk

Adverse event: atrio-ventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 52 at risk

Adverse event: symptomatic bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 52 at risk

Adverse event: symptomatic atrial arrhyhtmias
Serious: yes
Organ System: Cardiac disorders
Notes: serious: requiring hospitalizations
Frequency: 2 affected / 52 at risk

Adverse event: ventricular arrhyhtmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 52 at risk

Adverse event: Heart Failure exhacerbation
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 52 at risk

Adverse event: Miocardial Infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 52 at risk

Adverse event: Vascular encephalopathy
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 52 at risk

Adverse event: Chronic obstructive pulmonary disease (COPD)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Pacing lead dislodgment
Serious: yes
Organ System: Product Issues
Notes: requiring invasive system revision
Frequency: 1 affected / 52 at risk

Adverse event: Pacemaker system infection
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 52 at risk

Adverse event: Gastrointestinal disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 52 at risk

Adverse event: Musculoskeletal trauma
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 52 at risk

Adverse event: Nephropathy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 52 at risk

Adverse event: Urinary disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 52 at risk

Adverse event: Fever/virus
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 52 at risk

Adverse event: Neoplasm
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 52 at risk

Adverse event: Dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 52 at risk

Adverse event: symptomatic Atrial Arrhythmias
Serious: no
Organ System: Cardiac disorders
Notes: non-serious: not requiring hospitalisation
Frequency: 2 affected / 52 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Notes: non-serious: treated with variation to medical therapy
Frequency: 4 affected / 52 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 52 at risk

Adverse event: pacemaker signal oversensing/undersensing
Serious: no
Organ System: Product Issues
Notes: non serious: resolved with pacemaker reprogramming
Frequency: 9 affected / 52 at risk

Adverse event: pacemaker: rise in pacing threshold
Serious: no
Organ System: Product Issues
Notes: non serious: resolved with pacemaker reprogramming
Frequency: 3 affected / 52 at risk