Study: NCT01085435

Adverse event: Inappropriate Shock: SVT Above Discrimination Zone (Normal Device Function)
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 984 at risk

Adverse event: Inappropriate Shock: Cardiac Oversensing
Serious: yes
Organ System: Product Issues
Frequency: 10 affected / 984 at risk

Adverse event: Inappropriate Shock: Non-Cardiac Oversensing
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 984 at risk

Adverse event: PG Movement
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 984 at risk

Adverse event: Erosion
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 984 at risk

Adverse event: Inability to Communicate with the Device
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 984 at risk

Adverse event: Fear of Shocks
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 984 at risk

Adverse event: Imminent Erosion
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 984 at risk

Adverse event: Suspected Device Malfunction
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 984 at risk

Adverse event: Incision/Superficial Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 984 at risk

Adverse event: System Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 984 at risk

Adverse event: Atrial Fibrillation/Flutter (Procedure related)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 984 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 984 at risk

Adverse event: Sub-optimal Electrode position
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 984 at risk

Adverse event: Adverse Reaction (Medications)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 984 at risk

Adverse event: Adverse Reaction (General)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 984 at risk

Adverse event: Electrode Movement
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 984 at risk

Adverse event: Bleeding (Procedure related)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 984 at risk

Adverse event: Postoperative Limited Emphysema
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 984 at risk

Adverse event: Atrial Fibrillation/Flutter (Cardiac)
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 984 at risk

Adverse event: Heart Failure/Worsening of Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 46 affected / 984 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 984 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 984 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 984 at risk

Adverse event: Syncope (Cardiac)
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 984 at risk

Adverse event: Worsening of VT/VF
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 984 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 984 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 984 at risk

Adverse event: Chest Pain (Cardiac)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 984 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 984 at risk

Adverse event: Bradycardia/AV Block
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 984 at risk

Adverse event: Bundle branch block right
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 984 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 984 at risk

Adverse event: Stroke (Non-System/Non-Procedure related)
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 984 at risk

Adverse event: Infection not related to S-ICD System
Serious: yes
Organ System: Infections and infestations
Frequency: 16 affected / 984 at risk

Adverse event: Mental disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 984 at risk

Adverse event: Pain/Discomfort (Non-Cardiac/Non-System/Non-Procedure related)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 984 at risk

Adverse event: Pneumothorax (Non-System/Non-Procedure related)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 984 at risk

Adverse event: GI Disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 984 at risk

Adverse event: Abnormal Thyroid Condition
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 984 at risk

Adverse event: Bleeding (Non-System/Non-Procedure related)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 984 at risk

Adverse event: Implant/Replacement of Any Concomitant Device
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 984 at risk

Adverse event: Fracture/Broken Bone
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 984 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 11 affected / 984 at risk

Adverse event: Kidney Disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 984 at risk

Adverse event: Trauma (Non-Cardiac/Non-System/Non-Procedure related)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 984 at risk

Adverse event: HEENT Disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 984 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Cause unknown, no information available to determine the cause of the death
Frequency: 7 affected / 984 at risk

Adverse event: Neurological
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 984 at risk

Adverse event: Other (Non-Cardiac/Non-System/Non-Procedure related)
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 984 at risk

Adverse event: Metabolic disorder
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 984 at risk

Adverse event: Multi-system Failure
Serious: yes
Organ System: General disorders
Frequency: 18 affected / 984 at risk

Adverse event: Other: Cardiac (Non-System/Procedure related)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 984 at risk

Adverse event: Respiratory Failure (Non-Cardiac/Non-System/Non-Procedure related)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 984 at risk

Adverse event: Unable to Convert: During Procedure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 984 at risk

Adverse event: Inappropriate Shock: SVT Above Discrimination Zone (Normal Device Function)
Serious: no
Organ System: Product Issues
Frequency: 23 affected / 984 at risk

Adverse event: Inappr. Shock: Conv. bef. shock (Normal Function)
Serious: no
Organ System: Product Issues
Notes: Inappropriate Shock: Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) spontaneously converted immediately before shock (Normal Device Function)
Frequency: 1 affected / 984 at risk

Adverse event: Inappropriate Shock: Cardiac Oversensing
Serious: no
Organ System: Product Issues
Frequency: 105 affected / 984 at risk

Adverse event: Adverse Reaction (Bradycardia)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 984 at risk

Adverse event: Inappropriate Shock: Non-Cardiac Oversensing
Serious: no
Organ System: Product Issues
Frequency: 25 affected / 984 at risk

Adverse event: Adverse Reaction (Medications)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 984 at risk

Adverse event: Inappropriate Shock: Discrimination Error
Serious: no
Organ System: Product Issues
Frequency: 6 affected / 984 at risk

Adverse event: Adverse Reaction (Respiratory)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 984 at risk

Adverse event: Phantom Shock
Serious: no
Organ System: Product Issues
Frequency: 10 affected / 984 at risk

Adverse event: Premature Cell Battery Depletion: Premature Declaration
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 984 at risk

Adverse event: Atrial Fibrillation/Flutter (Procedure related)
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 984 at risk

Adverse event: Premature Cell Battery Depletion: Random Component Failure
Serious: no
Organ System: Product Issues
Frequency: 5 affected / 984 at risk

Adverse event: Bleeding (Procedure related)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 984 at risk

Adverse event: PG Movement
Serious: no
Organ System: Product Issues
Frequency: 8 affected / 984 at risk

Adverse event: Inability to Communicate with the Device
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 984 at risk

Adverse event: Phantom Vibration
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 984 at risk

Adverse event: Phantom Beeps
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 984 at risk

Adverse event: Erosion
Serious: no
Organ System: Product Issues
Frequency: 16 affected / 984 at risk

Adverse event: Discomfort
Serious: no
Organ System: Product Issues
Frequency: 74 affected / 984 at risk

Adverse event: Imminent Erosion
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 984 at risk

Adverse event: Electrode Movement
Serious: no
Organ System: Product Issues
Frequency: 8 affected / 984 at risk

Adverse event: Fear of Shocks
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 984 at risk

Adverse event: Electrode damaged and replaced during concomitant device procedure
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 984 at risk

Adverse event: Suspected Device Malfunction
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 984 at risk

Adverse event: Undersensing: Defibrillation
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 984 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 984 at risk

Adverse event: Fluid Accumulation (Procedure related)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 984 at risk

Adverse event: Programmer/Software Error code
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 984 at risk

Adverse event: Inappropriate Post Shock Pacing
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 984 at risk

Adverse event: Haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 30 affected / 984 at risk

Adverse event: Inadequate Pocket Size
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 984 at risk

Adverse event: Inadequate/Prolonged Healing of Incision Site
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 984 at risk

Adverse event: Incision/Superficial Infection
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 984 at risk

Adverse event: Keloid scar
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 984 at risk

Adverse event: Nerve Damage (Procedure related)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 984 at risk

Adverse event: System Infection
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 984 at risk

Adverse event: Sub-optimal Electrode position
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 984 at risk

Adverse event: Syncope (Procedure related)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 984 at risk

Adverse event: Sub-optimal PG position
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 984 at risk

Adverse event: Sub-optimal PG and Electrode position
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 984 at risk

Adverse event: Redness/Irritation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 984 at risk

Adverse event: Seroma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 984 at risk

Adverse event: Subcutaneous emphysema
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 984 at risk

Adverse event: Suture Discomfort
Serious: no
Organ System: Product Issues
Frequency: 6 affected / 984 at risk

Adverse event: Device malfunction
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 984 at risk

Adverse event: Other (Procedure related: PG)
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 984 at risk

Adverse event: Other (Procedure related: Electrode)
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 984 at risk

Adverse event: Atrial Fibrillation/Flutter (Cardiac)
Serious: no
Organ System: Cardiac disorders
Frequency: 34 affected / 984 at risk

Adverse event: Heart Failure/Worsening of Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 48 affected / 984 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 984 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 984 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 984 at risk

Adverse event: Syncope (Cardiac)
Serious: no
Organ System: Cardiac disorders
Frequency: 22 affected / 984 at risk

Adverse event: Near Syncope/Dizziness/Shortness of Breath/Confusion (Cardiac)
Serious: no
Organ System: Cardiac disorders
Frequency: 19 affected / 984 at risk

Adverse event: VT below Conditional Zone
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 984 at risk

Adverse event: Worsening of VT/VF
Serious: no
Organ System: Cardiac disorders
Frequency: 69 affected / 984 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 34 affected / 984 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 984 at risk

Adverse event: Chest Pain (Cardiac)
Serious: no
Organ System: Cardiac disorders
Frequency: 24 affected / 984 at risk

Adverse event: Peripheral vascular disorder
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 984 at risk

Adverse event: Bradycardia/AV Block
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 984 at risk

Adverse event: Inflammation (Cardiac)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 984 at risk

Adverse event: Bundle branch block right
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 984 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 984 at risk

Adverse event: Stroke (Non-System/Non-Procedure related)
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 984 at risk

Adverse event: Syncope (Non-Cardiac/Non-System/Non-Procedure related)
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 984 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 984 at risk

Adverse event: Infection not related to S-ICD System
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 984 at risk

Adverse event: Hematoma (Non-System/Non-Procedure related)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 984 at risk

Adverse event: Hematoma (Post Explant of S-ICD System)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 984 at risk

Adverse event: Near Syncope/Dizziness/Shortness of Breath/Confusion (Non-Cardiac/Non-System/Non-Procedure related)
Serious: no
Organ System: Cardiac disorders
Frequency: 18 affected / 984 at risk

Adverse event: Shortness of Breath, Dyspnea (Non-Cardiac/Non-System/Non-Procedure related)
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 984 at risk

Adverse event: Mental disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 984 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 984 at risk

Adverse event: Pain/Discomfort (Non-Cardiac/Non-System/Non-Procedure related)
Serious: no
Organ System: General disorders
Frequency: 21 affected / 984 at risk

Adverse event: Appendicitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 984 at risk

Adverse event: Pleural Effusion (Non-System/Non-Procedure related)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 984 at risk

Adverse event: GI Disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 984 at risk

Adverse event: Abnormal Thyroid Condition
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 984 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 984 at risk

Adverse event: Bleeding (Non-System/Non-Procedure related)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 984 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: General disorders
Frequency: 3 affected / 984 at risk

Adverse event: Repositioning of Any Concomitant Device
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 984 at risk

Adverse event: Implant/Replacement of Any Concomitant Device
Serious: no
Organ System: Product Issues
Frequency: 7 affected / 984 at risk

Adverse event: Inflammation (Non-Cardiac/Non-System/Non-Procedure related)
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 984 at risk

Adverse event: Fracture/Broken Bone
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 984 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 984 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 984 at risk

Adverse event: Kidney Disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 984 at risk

Adverse event: Trauma (Non-Cardiac/Non-System/Non-Procedure related)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 984 at risk

Adverse event: HEENT Disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 984 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 984 at risk

Adverse event: Fluid Accumulation (Non-Cardiac/Non-System/Non-Procedure related)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 984 at risk

Adverse event: Influenza
Serious: no
Organ System: General disorders
Frequency: 1 affected / 984 at risk

Adverse event: Genital/Urinary
Serious: no
Organ System: General disorders
Frequency: 1 affected / 984 at risk

Adverse event: Neurological
Serious: no
Organ System: General disorders
Frequency: 1 affected / 984 at risk

Adverse event: Other (Non-Cardiac/Non-System/Non-Procedure related)
Serious: no
Organ System: General disorders
Frequency: 11 affected / 984 at risk

Adverse event: Metabolic disorder
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 984 at risk

Adverse event: Abnormal Lab Values
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 984 at risk

Adverse event: Mitral valve incompetence
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 984 at risk

Adverse event: Other: Cardiac (Non-System/Procedure related)
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 984 at risk

Adverse event: Respiratory Failure (Non-Cardiac/Non-System/Non-Procedure related)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 984 at risk

Adverse event: Unable to Convert: During Procedure
Serious: no
Organ System: General disorders
Frequency: 9 affected / 984 at risk

Adverse event: Adverse Reaction (Medications) (Non-System/Non-Procedure related)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 984 at risk

Adverse event: Altered Mental Status
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 984 at risk

Adverse event: Hypertension
Serious: no
Organ System: General disorders
Frequency: 3 affected / 984 at risk

Adverse event: Muscle Stimulation (Non-System/Non-Procedure related)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 984 at risk

Adverse event: Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 984 at risk

Adverse event: Unable to Convert: During Spontaneous Episode
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 984 at risk