Study: NCT00180297

Adverse event: Abdominal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 107 at risk

Adverse event: Ablation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 107 at risk

Adverse event: Angioplasty
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 107 at risk

Adverse event: Arrhythmic storm
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 107 at risk

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

Adverse event: Cardioversion
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 107 at risk

Adverse event: Cholesystectomy
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 107 at risk

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

Adverse event: Cardiac Resynchronization Therapy - Defibrillator
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 107 at risk

Adverse event: Dental
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 107 at risk

Adverse event: Defibrillation thhreshold
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 107 at risk

Adverse event: Dislodgement
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 107 at risk

Adverse event: Drug
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 107 at risk

Adverse event: Effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 107 at risk

Adverse event: End of life
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 107 at risk

Adverse event: Explant Intracardiac defibrillator
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 107 at risk

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

Adverse event: Heart transplant
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 107 at risk

Adverse event: Hematoma/Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 107 at risk

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

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 107 at risk

Adverse event: Hypoglycemie
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 107 at risk

Adverse event: Intracardiac Defibrillator Programming
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 107 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 107 at risk

Adverse event: Left Ventricular assistance
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 107 at risk

Adverse event: Mitral Valve
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 107 at risk

Adverse event: Neurologic
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 107 at risk

Adverse event: Other
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 107 at risk

Adverse event: Pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 107 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 107 at risk

Adverse event: Pocket infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 107 at risk

Adverse event: premature End of Life
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 107 at risk

Adverse event: prostate
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 107 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 107 at risk

Adverse event: reprogramming
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 107 at risk

Adverse event: Thyroid
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 107 at risk

Adverse event: Vagal syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 107 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 107 at risk

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

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

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

Adverse event: Dysphagy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 107 at risk

Adverse event: healing issue
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 107 at risk

Adverse event: Impedance > 3000
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 107 at risk

Adverse event: Implant
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 107 at risk

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

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

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

Adverse event: Psychologic
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 107 at risk

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

Adverse event: Site of puncture
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 107 at risk

Adverse event: Thyroid
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 107 at risk

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

Adverse event: Inappropriate programming
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 107 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 108 at risk

Adverse event: Aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 108 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 108 at risk

Adverse event: Aorto Femoro Bypass
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 108 at risk

Adverse event: Arrhythmic storm
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 108 at risk

Adverse event: Artheritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 108 at risk

Adverse event: Antivitamin K Overdose
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 108 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 108 at risk

Adverse event: Bypass
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 108 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 108 at risk

Adverse event: Cardioversion
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 108 at risk

Adverse event: Carotid
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 108 at risk

Adverse event: Cardiac Resynchronization Therapy - Defibrillator
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 108 at risk

Adverse event: Cardiovascular Accident (CVA)
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 108 at risk

Adverse event: Defibrillation thhreshold
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 108 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 108 at risk

Adverse event: Dislodgement
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 108 at risk

Adverse event: Drug
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 108 at risk

Adverse event: End of life
Serious: yes
Organ System: Product Issues
Frequency: 4 affected / 108 at risk

Adverse event: Explant System
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 108 at risk

Adverse event: Eye
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 108 at risk

Adverse event: Failure
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 108 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 108 at risk

Adverse event: Gout
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 108 at risk

Adverse event: Heart transplant
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 108 at risk

Adverse event: Hematoma/Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 108 at risk

Adverse event: Hematoma/infection at implant
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 108 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 108 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 108 at risk

Adverse event: Neurologic
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 108 at risk

Adverse event: Orthopedic
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 108 at risk

Adverse event: Orthostatic
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 108 at risk

Adverse event: Oversensing
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 108 at risk

Adverse event: Peripheral angioplasty
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 108 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 108 at risk

Adverse event: Lung disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 108 at risk

Adverse event: post sternotomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 108 at risk

Adverse event: Pre-transplant
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 108 at risk

Adverse event: premature End of Life
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 108 at risk

Adverse event: prostate
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 108 at risk

Adverse event: renal angioplasty
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 108 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 108 at risk

Adverse event: Rhumatism
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 108 at risk

Adverse event: scar dehiscence
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 108 at risk

Adverse event: N/A
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 108 at risk

Adverse event: urogenital
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 108 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 108 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 108 at risk

Adverse event: Angor
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 108 at risk

Adverse event: diet
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 108 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 108 at risk

Adverse event: Inappropriate Therapy
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 108 at risk

Adverse event: Limit algorhythm
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 108 at risk

Adverse event: Loss Capture
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 108 at risk

Adverse event: Neurologic
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 108 at risk

Adverse event: Oversensing
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 108 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 108 at risk

Adverse event: Rhythm ID
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 108 at risk

Adverse event: Smart sensing
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 108 at risk

Adverse event: Sternotomy wires
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 108 at risk

Adverse event: Tricuspid valve incompetence
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 108 at risk

Adverse event: Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 108 at risk

Adverse event: Neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 108 at risk

Adverse event: Inappropriate programming
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 108 at risk