Study: NCT01736618

Adverse event: Heart Failure (HF)/ Worsening HF
Serious: yes
Organ System: Cardiac disorders
Frequency: 63 affected / 1766 at risk

Adverse event: Worsening VT/VF
Serious: yes
Organ System: Cardiac disorders
Notes: Worsening Ventricular Tachycardia/Ventricular Fibrillation - Cardiovascular related
Frequency: 50 affected / 1766 at risk

Adverse event: Chest Pain - Cardiovascular related
Serious: yes
Organ System: Cardiac disorders
Frequency: 25 affected / 1766 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 25 affected / 1766 at risk

Adverse event: Atrial Fibrillation / Atrial Flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 23 affected / 1766 at risk

Adverse event: Bradycardia/ AV Block
Serious: yes
Organ System: Cardiac disorders
Frequency: 21 affected / 1766 at risk

Adverse event: Pulseless Electrical Activity (PEA)
Serious: yes
Organ System: Cardiac disorders
Frequency: 20 affected / 1766 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 1766 at risk

Adverse event: Other -Cardiovascular related
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 1766 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1766 at risk

Adverse event: Premature Ventricular Contractions (PVC)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1766 at risk

Adverse event: Supraventricular Tachycardia (SVT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1766 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1766 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1766 at risk

Adverse event: Inflammation - Cardiovascular related
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1766 at risk

Adverse event: Gastrointestinal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 1766 at risk

Adverse event: Multisystem Failure - Other
Serious: yes
Organ System: General disorders
Frequency: 53 affected / 1766 at risk

Adverse event: Death - unknown cause
Serious: yes
Organ System: General disorders
Frequency: 38 affected / 1766 at risk

Adverse event: Syncope - Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 1766 at risk

Adverse event: Near Syncope/Dizziness/Shortness of Breath/Confusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1766 at risk

Adverse event: Syncope - Non-cardiovascular
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 1766 at risk

Adverse event: Chest pain - Non-cardiac other
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 1766 at risk

Adverse event: Abnormal Laboratory Values
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 1766 at risk

Adverse event: Multiple Symptoms
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1766 at risk

Adverse event: Near Syncope/Dizziness/Shortness of Breath/Confusion
Serious: yes
Organ System: General disorders
Notes: Non-Cardiovascular
Frequency: 1 affected / 1766 at risk

Adverse event: Other - Patient Condition - Non-cardiovascular
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1766 at risk

Adverse event: Infection - Non-device/procedure related
Serious: yes
Organ System: Infections and infestations
Frequency: 49 affected / 1766 at risk

Adverse event: Infection - S-ICD System/Implant Procedure related
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 45 affected / 1766 at risk

Adverse event: Hematoma <= 30 days post-implant - Procedure related
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 1766 at risk

Adverse event: Infection - Incisional/Superficial Infection - Procedure related
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 1766 at risk

Adverse event: Adverse Reaction - Hypotension - Procedure related
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 1766 at risk

Adverse event: Discomfort - Post-op > 30-Days - Device related
Serious: yes
Organ System: Product Issues
Frequency: 5 affected / 1766 at risk

Adverse event: Sub-optimal Electrode Position - Procedure related
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 1766 at risk

Adverse event: Adverse Reaction to Medications - Procedure related
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1766 at risk

Adverse event: Elective Device Replacement
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Replacement of the S-ICD
Frequency: 3 affected / 1766 at risk

Adverse event: Electrode Movement - Procedure related
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1766 at risk

Adverse event: Inadequate healing of incision site - Procedure related
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1766 at risk

Adverse event: Trauma - Other
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Non-device system related trauma
Frequency: 3 affected / 1766 at risk

Adverse event: Cardiac arrest - Procedure related
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1766 at risk

Adverse event: Electrode movement - Electrode related
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 1766 at risk

Adverse event: Respiratory Failure - Procedure related
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1766 at risk

Adverse event: Adverse Reaction Respiratory - Procedure Related
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1766 at risk

Adverse event: Bleeding - Procedure related
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1766 at risk

Adverse event: Fever - Procedure related
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1766 at risk

Adverse event: Heart Failure / Worsening of Heart Failure - Procedure related
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1766 at risk

Adverse event: Hematoma - Pocket (> 30 days post-implant)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1766 at risk

Adverse event: Hematoma > 30 days post-implant - Procedure related
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1766 at risk

Adverse event: PG movement / Revision - Other
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1766 at risk

Adverse event: Pleural Effusion - Procedure related
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1766 at risk

Adverse event: Pneumothorax - Procedure related
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1766 at risk

Adverse event: Pulseless Electrical Activity (PEA) Post Anesthesia prior to Implant
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1766 at risk

Adverse event: Seroma - Procedure related
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1766 at risk

Adverse event: Sub-optimal device and electrode position - Procedure related
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1766 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 15 affected / 1766 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1766 at risk

Adverse event: Inappropriate Shock - Inappropriate Sensing: Cardiac Oversensing
Serious: yes
Organ System: Product Issues
Frequency: 57 affected / 1766 at risk

Adverse event: Inappropriate Shock - Inappropriate Sensing: Extra-cardiac Oversensing
Serious: yes
Organ System: Product Issues
Frequency: 12 affected / 1766 at risk

Adverse event: Inappropriate Shock - Above Programmed Rate Zone
Serious: yes
Organ System: Product Issues
Frequency: 11 affected / 1766 at risk

Adverse event: Premature Cell Battery Depletion
Serious: yes
Organ System: Product Issues
Frequency: 11 affected / 1766 at risk

Adverse event: Inappropriate Shock - Inappropriate Sensing: Discrimination Error
Serious: yes
Organ System: Product Issues
Frequency: 6 affected / 1766 at risk

Adverse event: Unable to Convert - During Device System Implant Procedure
Serious: yes
Organ System: Product Issues
Frequency: 6 affected / 1766 at risk

Adverse event: Erosion - Device related
Serious: yes
Organ System: Product Issues
Frequency: 6 affected / 1766 at risk

Adverse event: Appropriate Shock - Accelerated Arrhythmia
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1766 at risk

Adverse event: Electrode Conductor Fracture- Presumed Twiddler's Syndrome
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1766 at risk

Adverse event: Erosion - Electrode related
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1766 at risk

Adverse event: Erosion - Imminent Erosion - Device related
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1766 at risk

Adverse event: Inability to Communicate with the Device
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1766 at risk

Adverse event: Inappropriate Shock - Inappropriate Sensing: Baseline Shift
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1766 at risk

Adverse event: Trauma to Device
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1766 at risk

Adverse event: Unable to Convert - During Device Testing Procedure >150 days - Patient condition
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1766 at risk

Adverse event: Undersensing - Device related
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1766 at risk

Adverse event: Mental disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 1766 at risk

Adverse event: Kidney Disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 12 affected / 1766 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 1766 at risk

Adverse event: Shortness of Breath/Dyspnea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1766 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1766 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1766 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Vascular disorders
Frequency: 29 affected / 1766 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 24 affected / 1766 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 1766 at risk

Adverse event: Bleeding - Other
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 1766 at risk

Adverse event: Stroke - Procedure related
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 1766 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 1766 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1766 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1766 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 1766 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 1766 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1766 at risk

Adverse event: Discomfort - Post-op ≤ 30-Days - Procedure related
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 1766 at risk

Adverse event: Discomfort - Post-op ≤ 30-Days - Device related
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 1766 at risk

Adverse event: Device Movement - Revision
Serious: yes
Organ System: Product Issues
Frequency: 5 affected / 1766 at risk

Adverse event: Inappropriate Shock - Inappropriate Sensing: Cardiac Oversensing
Serious: no
Organ System: Product Issues
Frequency: 109 affected / 1766 at risk

Adverse event: Inappropriate Shock - Inappropriate Sensing: Extra-cardiac Oversensing
Serious: no
Organ System: Product Issues
Frequency: 46 affected / 1766 at risk

Adverse event: Discomfort - Post-op > 30-Days - Device related
Serious: no
Organ System: Product Issues
Frequency: 25 affected / 1766 at risk

Adverse event: Incisional/Superficial Infection - Procedure related
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 24 affected / 1766 at risk

Adverse event: Hematoma <= 30 days post-implant - Procedure related
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 21 affected / 1766 at risk

Adverse event: Discomfort - Post-op ≤ 30-Days - Procedure related
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 22 affected / 1766 at risk