Study: NCT01064076

Adverse event: Cyst
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 321 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 321 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 321 at risk

Adverse event: Adverse Reaction to Medication
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 321 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 321 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 321 at risk

Adverse event: Erosioin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 321 at risk

Adverse event: GI Disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 321 at risk

Adverse event: Heart Failure/Worsening of Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 321 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 321 at risk

Adverse event: Inability to Communicate with the Device
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 321 at risk

Adverse event: Inappropriate Shock: Oversensing
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 321 at risk

Adverse event: Inappropriate Shock: SVT Above Discrimination Zone (Normal Device Function)
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 321 at risk

Adverse event: Incomplete Electrode Connection to the Device
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 321 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 321 at risk

Adverse event: Near Syncope/Dizziness/Shortness of Breath/Confusion
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 321 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 321 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 321 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 321 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 321 at risk

Adverse event: Sub-optimal Electrode Position
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 321 at risk

Adverse event: Suspected Device Malfunction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 321 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 321 at risk

Adverse event: Device System Infection - Explant
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 321 at risk

Adverse event: VT Below Conditional Zone
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 321 at risk

Adverse event: Worsening of Benign Prostatic Hyperplasia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 321 at risk

Adverse event: Worsening of VT/VF
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 321 at risk

Adverse event: Adverse Reaction to Medication
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 321 at risk

Adverse event: Atrial Fibrillation/Flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 17 affected / 321 at risk

Adverse event: Discomfort
Serious: no
Organ System: General disorders
Frequency: 23 affected / 321 at risk

Adverse event: Haematoma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 5 affected / 321 at risk

Adverse event: Inadequate/Prolonged Healing of Incision Site
Serious: no
Organ System: Surgical and medical procedures
Frequency: 5 affected / 321 at risk

Adverse event: Inappropriate Shock
Serious: no
Organ System: General disorders
Frequency: 45 affected / 321 at risk

Adverse event: Incision/Superficial Infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 321 at risk

Adverse event: Phantom Shock
Serious: no
Organ System: General disorders
Frequency: 4 affected / 321 at risk

Adverse event: Suboptimal Pulse Generator and/or Electrode Position
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 321 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Frequency: 4 affected / 321 at risk