Study: NCT01841554

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: CEC Adjudicated
Frequency: 2 affected / 62 at risk

Adverse event: Atrial septal defect
Serious: yes
Organ System: Cardiac disorders
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Bundle branch block left
Serious: yes
Organ System: Cardiac disorders
Notes: CEC Adjudicated
Frequency: 2 affected / 62 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: CEC Adjudicated
Frequency: 2 affected / 62 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: CEC Adjudicated
Frequency: 15 affected / 62 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Cardiac disorders
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Mitral valve disease
Serious: yes
Organ System: Cardiac disorders
Notes: CEC Adjudicated
Frequency: 4 affected / 62 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: CEC Adjudicated
Frequency: 2 affected / 62 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Notes: CEC Adjudicated
Frequency: 3 affected / 62 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: CEC Adjudicated
Frequency: 3 affected / 62 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Melaena
Serious: yes
Organ System: Gastrointestinal disorders
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: General disorders
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Oedema due to cardiac disease
Serious: yes
Organ System: General disorders
Notes: CEC Adjudicated
Frequency: 2 affected / 62 at risk

Adverse event: Systemic inflammatory response syndrome
Serious: yes
Organ System: General disorders
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: CEC Adjudicated
Frequency: 2 affected / 62 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Notes: CEC Adjudicated
Frequency: 2 affected / 62 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Iatrogenic injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: CEC Adjudicated
Frequency: 2 affected / 62 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Blood glucose increased
Serious: yes
Organ System: Investigations
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Investigations
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Troponin increased
Serious: yes
Organ System: Investigations
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Meniscus injury
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Carcinoma in situ of eye
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Large intestine polyp
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Ovarian cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Haemorrhagic stroke
Serious: yes
Organ System: Nervous system disorders
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Nervous system disorders
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: CEC Adjudicated
Frequency: 4 affected / 62 at risk

Adverse event: Actinomycotic pulmonary infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Cardiac pacemaker replacement
Serious: yes
Organ System: Surgical and medical procedures
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Implantable defibrillator insertion
Serious: yes
Organ System: Surgical and medical procedures
Notes: CEC Adjudicated
Frequency: 1 affected / 62 at risk

Adverse event: Air embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 62 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 62 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 62 at risk

Adverse event: Device fastener issue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 62 at risk

Adverse event: Post procedural haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 62 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 62 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 62 at risk