Study: NCT00583791

Adverse event: AE Code Not Specified
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Anemias
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Anemias Caused By Blood Loss
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Arterial Pulse Loss
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Blood Loss
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 91 at risk

Adverse event: Transfusion
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 91 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Cardiac perforation
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Cardiac Surgery
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Death1
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 91 at risk

Adverse event: Delivery System Failure
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Device Collapse2
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Device Embolization3
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Dual Pacemaker
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Haematoma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Hemostasis and Coagulation Disorders
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Hypotension
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 91 at risk

Adverse event: Mobitz II Block
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Poor Device Position
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Seizure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Subaortic Stenosis
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Third Degree Heart Block (Complete Heart Block)
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 91 at risk

Adverse event: Vocal cord paralysis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: AE Code Not Specified
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Acidosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Bronchitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Acute Erosive Gastritis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Acute Otitis Media
Serious: no
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Pancreatitis acute
Serious: no
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Anemias
Serious: no
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Anemias Caused By Blood Loss
Serious: no
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Anemias Caused By Deficient Erythropoiesis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Anesthesia Reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Arrhythmias
Serious: no
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Arterial Pulse Loss
Serious: no
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Asthma
Serious: no
Organ System: General disorders
Frequency: 4 affected / 91 at risk

Adverse event: Atelectasis
Serious: no
Organ System: General disorders
Frequency: 8 affected / 91 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Bacteraemia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 91 at risk

Adverse event: Bacterial Infections
Serious: no
Organ System: General disorders
Frequency: 4 affected / 91 at risk

Adverse event: Biventricular Hypertrophy/Combined Ventricular Hypertrophy
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Blood Loss
Serious: no
Organ System: General disorders
Frequency: 5 affected / 91 at risk

Adverse event: Transfusion
Serious: no
Organ System: General disorders
Frequency: 6 affected / 91 at risk

Adverse event: Bradycardia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 91 at risk

Adverse event: Broad QRS Complex Arrhythmias
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Bronchomalacia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Bruise/Purpura Simplex
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: CVVH (Continuous Veno Venous Hemofiltration)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Cardiac arrest
Serious: no
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Cardiac perforation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Cardiac Cath
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Cardiac Surgery
Serious: no
Organ System: General disorders
Frequency: 13 affected / 91 at risk

Adverse event: Cardiomyopathy
Serious: no
Organ System: General disorders
Frequency: 3 affected / 91 at risk

Adverse event: Cellulitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 91 at risk

Adverse event: Cholecystitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Chronic Recurrent Drainage/Oozing
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Circumcision
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Coarctation of the aorta
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Cobra Formation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Common Cold/Upper Respiratory Tract Infection
Serious: no
Organ System: General disorders
Frequency: 9 affected / 91 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Croup infectious
Serious: no
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Cyanosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Death*
Serious: no
Organ System: General disorders
Frequency: 4 affected / 91 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Delivery System Failure
Serious: no
Organ System: General disorders
Frequency: 4 affected / 91 at risk

Adverse event: Device Collapse
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Device embolisation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 91 at risk

Adverse event: Dual Pacemaker
Serious: no
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: General disorders
Frequency: 4 affected / 91 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 91 at risk

Adverse event: Elective surgery
Serious: no
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Elective Adenoidectomy with Tympanostomy Tubes
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 91 at risk

Adverse event: First Degree Heart/AV Block/Cardiac Arrhythmia - 1st Degree AV Block
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Foreign Bodies
Serious: no
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Fracture
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Functional Vomiting
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Fungal Pneumonia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: General disorders
Frequency: 4 affected / 91 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Gastrostomy Tube
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 91 at risk

Adverse event: Haematoma
Serious: no
Organ System: General disorders
Frequency: 4 affected / 91 at risk

Adverse event: Hematoma of the Groin
Serious: no
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Haematuria
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Hemostasis and Coagulation Disorders
Serious: no
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Frequency: 10 affected / 91 at risk

Adverse event: Bundle branch block right
Serious: no
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Ingestion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Interventricular Conduction Delay
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Junctional Escape Beat
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Junctional Escape Rhythm/Intermittent Junctional Rhythm
Serious: no
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Lacerations
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Left ventricular hypertrophy
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Hepatomegaly
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Urethral meatus stenosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Amnesia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Metabolic alkalosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Migraine
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Mild Mitral Valve Regurgitation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Mild Tricuspid Regurgitation
Serious: no
Organ System: General disorders
Frequency: 3 affected / 91 at risk

Adverse event: Miscellaneous Infections
Serious: no
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Mitral Valve Regurgitation/Mitral Insufficiency
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Mobitz II Block
Serious: no
Organ System: General disorders
Frequency: 5 affected / 91 at risk

Adverse event: Moderate Tricuspid Regurgitation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Myalgias
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Nonspecific Intraventricular Conduction Defects
Serious: no
Organ System: General disorders
Frequency: 3 affected / 91 at risk

Adverse event: Epistaxis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Otitis media
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Pallor
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Palpitations
Serious: no
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Paroxysmal Junctional Tachycardia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 91 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: General disorders
Frequency: 4 affected / 91 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Pleural Effusions
Serious: no
Organ System: General disorders
Frequency: 3 affected / 91 at risk

Adverse event: Pleuropericardial Fluid
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Pneumonia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 91 at risk

Adverse event: Pneumonia Caused By Gram-Negative Bacilli
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Poor Device Position
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Premature Atrial Beat
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Premature Ventricular Contraction
Serious: no
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Pulmonary congestion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Pulmonary haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Pulmonary valve stenosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: General disorders
Frequency: 6 affected / 91 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 3 affected / 91 at risk

Adverse event: Renal failure
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Respiratory Synctial Virus Infection (RSV)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 91 at risk

Adverse event: Right Bundle Branch Block/Complete Right Bundle Branch Block
Serious: no
Organ System: General disorders
Frequency: 11 affected / 91 at risk

Adverse event: Right ventricular hypertrophy
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Scoliosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Seizure/Convulsions/Epilepsy
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Seizure
Serious: no
Organ System: General disorders
Frequency: 3 affected / 91 at risk

Adverse event: Sinusitis
Serious: no
Organ System: General disorders
Frequency: 5 affected / 91 at risk

Adverse event: Stridor
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Subaortic Stenosis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Subglottic Edema 2 to Prolonged Intubation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Tachypnoea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Third Degree Heart Block (Complete Heart Block)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 91 at risk

Adverse event: Trace Tricuspid Regurgitation (Tricuspid Incompetence or Ins)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Tracheostomy
Serious: no
Organ System: General disorders
Frequency: 2 affected / 91 at risk

Adverse event: Extrasystoles
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Urinary Tract Infections
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Vascular Congestion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Venous thrombosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Rhythm idioventricular
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: General disorders
Frequency: 3 affected / 91 at risk

Adverse event: Pneumonia viral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Vocal cord paralysis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 4 affected / 91 at risk