Study: NCT01075516

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 107 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 107 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 107 at risk

Adverse event: Decubitus ulcer
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 107 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 107 at risk

Adverse event: Renal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 107 at risk

Adverse event: Device inappropriate shock delivery
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 107 at risk

Adverse event: Lead dislodgement
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 107 at risk

Adverse event: Cardioversion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 107 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 107 at risk

Adverse event: Arterial disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 107 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 107 at risk

Adverse event: Cardiovascular event prophylaxis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 107 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 107 at risk

Adverse event: Colitis ulcerative
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 107 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 107 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 107 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 107 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 107 at risk

Adverse event: Eye symptoms
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 107 at risk

Adverse event: Device inappropriate shock delivery
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 107 at risk

Adverse event: Device malfunction
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 107 at risk

Adverse event: Device pacing issue
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 107 at risk

Adverse event: Device stimulation issue
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 107 at risk

Adverse event: Oversensing
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 107 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 102 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 102 at risk

Adverse event: Cardiac death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 102 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 102 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 102 at risk

Adverse event: Implant site infection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 102 at risk

Adverse event: Decubitus ulcer
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 102 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 102 at risk

Adverse event: Prostatic neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 102 at risk

Adverse event: Renal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 102 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 102 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 102 at risk

Adverse event: Device inappropriate shock delivery
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 102 at risk

Adverse event: Device stimulation issue
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 102 at risk

Adverse event: Lead dislodgement
Serious: yes
Organ System: Product Issues
Frequency: 6 affected / 102 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 102 at risk

Adverse event: Cardiac pacemaker insertion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 102 at risk

Adverse event: Cardioversion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 102 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 102 at risk

Adverse event: Medical device repositioning
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 102 at risk

Adverse event: Mitral valve replacement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 102 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 102 at risk

Adverse event: Syncope
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 102 at risk

Adverse event: Motor disfunction
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Hemorrage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 102 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 102 at risk

Adverse event: Blood pressure dicreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 102 at risk

Adverse event: Device capturing issue
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 102 at risk

Adverse event: Device electrical impedence issue
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 102 at risk

Adverse event: Device malfunction
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 102 at risk

Adverse event: Device pacing issue
Serious: no
Organ System: Product Issues
Frequency: 5 affected / 102 at risk

Adverse event: Device stimulation issue
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 102 at risk

Adverse event: Device telemetry issue
Serious: no
Organ System: Product Issues
Frequency: 5 affected / 102 at risk

Adverse event: Oversensing
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 102 at risk

Adverse event: Undersensing
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 102 at risk