Study: NCT00944125

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: disorder characterized by an uncomfortable sensation of difficulty breathing.
Frequency: 1 affected / 41 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: (exacerbation of existing condition) A disorder characterized by the inability of the heart to pump blood at an adequate volume to meet tissue metabolic requirements, or, the ability to do so only at an elevation in the filling pressure.
Frequency: 2 affected / 41 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: (not related to investigation)
Frequency: 1 affected / 41 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Notes: (not related to investigation) A disorder characterized by progressive deterioration of the lungs, liver, kidney and clotting mechanisms.
Frequency: 1 affected / 41 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: A disorder characterized by the presence of pathogenic microorganisms in the blood stream that cause a rapidly progressing systemic reaction that may lead to shock.
Frequency: 2 affected / 41 at risk

Adverse event: Gastrointestinal disorders - Other, specify
Serious: yes
Organ System: Gastrointestinal disorders
Notes: GI bleed, non specific
Frequency: 1 affected / 41 at risk

Adverse event: ICD shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 41 at risk

Adverse event: Lead dislodgement
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 41 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: A disorder characterized by an reduction in the amount of hemoglobin in 100 ml of blood.
Frequency: 1 affected / 41 at risk

Adverse event: Diaphragmatic Stimulation
Serious: no
Organ System: General disorders
Notes: Simulation of the phrenic nerve or diaphragm by a pacing output pulse, causing a hiccough-like reaction.
Frequency: 7 affected / 41 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: A disorder characterized by a state of generalized weakness with a pronounced inability to summon sufficient energy to accomplish daily activities.
Frequency: 3 affected / 41 at risk

Adverse event: Syncope
Serious: yes
Organ System: Vascular disorders
Notes: A disorder characterized by spontaneous loss of consciousness caused by insufficient blood supply to the brain.
Frequency: 1 affected / 41 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: disorder characterized by an uncomfortable sensation of difficulty breathing.
Frequency: 1 affected / 41 at risk

Adverse event: Fall
Serious: yes
Organ System: General disorders
Notes: A finding of sudden movement downward, usually resulting in injury.
Frequency: 2 affected / 41 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Notes: A disorder characterized by pathological irregularities in the cardiac conduction system.
Frequency: 2 affected / 41 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Renal and urinary disorders
Notes: A disorder characterized by laboratory test results that indicate an elevation in the concentration of potassium in the blood; associated with kidney failure or sometimes with the use of diuretic drugs.
Frequency: 1 affected / 41 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by the reflexive act of ejecting the contents of the stomach through the mouth.
Frequency: 1 affected / 41 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by a sensation of marked discomfort in the stomach.
Frequency: 1 affected / 41 at risk

Adverse event: Anal fistula
Serious: yes
Organ System: Gastrointestinal disorders
Notes: A disorder characterized by an abnormal communication between the rectum and another organ or anatomic site.
Frequency: 1 affected / 41 at risk

Adverse event: ICD shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 41 at risk

Adverse event: Diaphragmatic Stimulation
Serious: no
Organ System: General disorders
Notes: Simulation of the phrenic nerve or diaphragm by a pacing output pulse, causing a hiccough-like reaction.
Frequency: 3 affected / 41 at risk