Study: NCT00916344

Adverse event: Atrial fibrillation / flutter related
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 175 at risk

Adverse event: ablation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 175 at risk

Adverse event: acute circulation insufficiency
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 175 at risk

Adverse event: bypass operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 175 at risk

Adverse event: cardiac decompensation
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 175 at risk

Adverse event: cardiogenic shock during implantation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 175 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 175 at risk

Adverse event: coronary angiography
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 175 at risk

Adverse event: coronary artery disease related
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 175 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 175 at risk

Adverse event: Dementia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 175 at risk

Adverse event: diabetes related
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 175 at risk

Adverse event: dialysis related
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 175 at risk

Adverse event: fever and infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 175 at risk

Adverse event: foot amputation due to endocrine disorder
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 175 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 175 at risk

Adverse event: intestinal disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 175 at risk

Adverse event: joint and bone related
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 175 at risk

Adverse event: lead dislocation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 10 affected / 175 at risk

Adverse event: lifestyle modification
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 175 at risk

Adverse event: lung related hospitalisation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 175 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 175 at risk

Adverse event: minor myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 175 at risk

Adverse event: noise hypersensibility
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: non-cardiac death
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 175 at risk

Adverse event: non-cardiac death
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 175 at risk

Adverse event: pacemaker/ICD exchange/repositioning
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 175 at risk

Adverse event: pericardial effusion and pericardectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 175 at risk

Adverse event: pocket haematoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 175 at risk

Adverse event: spinal disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 175 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 175 at risk

Adverse event: Others
Serious: no
Organ System: General disorders
Frequency: 11 affected / 175 at risk

Adverse event: circulation problems
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 175 at risk

Adverse event: gastrointestinal disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 175 at risk

Adverse event: lead dislocation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 175 at risk

Adverse event: pacemaker related
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 175 at risk