Study: NCT00121472

Adverse event: Haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 117 affected / 194 at risk

Adverse event: Bleeding requiring surgery
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 56 affected / 194 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 17 affected / 194 at risk

Adverse event: Driveline infection
Serious: yes
Organ System: Infections and infestations
Frequency: 16 affected / 194 at risk

Adverse event: Pocket infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 194 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 35 affected / 194 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 36 affected / 194 at risk

Adverse event: Device thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 194 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 194 at risk

Adverse event: Other neurological
Serious: yes
Organ System: Nervous system disorders
Notes: Includes transient ischemic attachs (TIA) and non-stroke neurological events.
Frequency: 15 affected / 194 at risk

Adverse event: Local infection
Serious: yes
Organ System: Infections and infestations
Frequency: 45 affected / 194 at risk

Adverse event: Peripheral Thromboembolism
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 194 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 53 affected / 194 at risk

Adverse event: Cardiac arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 82 affected / 194 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 25 affected / 194 at risk

Adverse event: Hepatic dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 194 at risk

Adverse event: Psychological
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 194 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 194 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: General disorders
Notes: Non-serious bleeding events
Frequency: 16 affected / 194 at risk

Adverse event: Localised infection
Serious: no
Organ System: General disorders
Notes: Non-serious localized infection
Frequency: 15 affected / 194 at risk

Adverse event: Driveline Infection
Serious: no
Organ System: General disorders
Notes: Non-serious driveline infection
Frequency: 10 affected / 194 at risk

Adverse event: Cardiac Arrhythmias
Serious: no
Organ System: General disorders
Notes: Non-serious cardiac arrhythmias
Frequency: 29 affected / 194 at risk

Adverse event: Psychological
Serious: no
Organ System: General disorders
Notes: Non-serious psychological
Frequency: 10 affected / 194 at risk

Adverse event: Device Malfunctions
Serious: no
Organ System: General disorders
Notes: Non-serious device malfunctions
Frequency: 36 affected / 194 at risk