Study: NCT02433379

Adverse event: Abdominal discomfort
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Abnormal laboratory values
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 1116 at risk

Adverse event: Adverse drug reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Adverse reaction - Allergic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Adverse reaction - Medication
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Adverse reaction Hypotension Procedure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1116 at risk

Adverse event: Adverse reaction Medication/Anaphylactic shock Procedure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1116 at risk

Adverse event: Adverse reaction Respiratory Procedure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 1116 at risk

Adverse event: Alcohol abuse
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Atrial Fibrillation (AF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 17 affected / 1116 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1116 at risk

Adverse event: Atrial Tachycardia/Other SVT (eg AVRT, AVNRT, EAT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1116 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 1116 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 1116 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 1116 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 1116 at risk

Adverse event: Cerebrovascular Accident (CVA) - hemorrhagic
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Cerebrovascular Accident (CVA) - ischemic
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Cerebrovascular Accident (CVA) - unspecifed
Serious: yes
Organ System: Vascular disorders
Frequency: 13 affected / 1116 at risk

Adverse event: Chest pain - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 25 affected / 1116 at risk

Adverse event: Chest pain - Ischemic
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 1116 at risk

Adverse event: Chest pain - Other
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 1116 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 17 affected / 1116 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 1116 at risk

Adverse event: Deep Vein Thrombosis (DVT)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Device shocked 5 times before conversion
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1116 at risk

Adverse event: Device system discomfort (> 30d post implant)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1116 at risk

Adverse event: Device system infection (= 30d post implant with explant)
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 1116 at risk

Adverse event: Device system infection (>30d post implant with explant)
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1116 at risk

Adverse event: Dislodgment - Oversensing - RV Lead
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1116 at risk

Adverse event: Distal thromboemboli
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1116 at risk

Adverse event: Dizziness - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Drug related
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Dyspnea - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 31 affected / 1116 at risk

Adverse event: Electrode erosion
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Electrode migration/revision
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1116 at risk

Adverse event: Electrode migration/revision Procedure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1116 at risk

Adverse event: Electrode suture discomfort
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Endocrine
Serious: yes
Organ System: Endocrine disorders
Frequency: 12 affected / 1116 at risk

Adverse event: Fascial defect closure
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Fatigue - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1116 at risk

Adverse event: Fatigue/Weakness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Fever and/or Virus
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 1116 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 1116 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 1116 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 1116 at risk

Adverse event: Heart failure symptoms - Unspecified
Serious: yes
Organ System: Cardiac disorders
Frequency: 27 affected / 1116 at risk

Adverse event: Hematological
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1116 at risk

Adverse event: Hematoma - Unrelated (non study) procedure or device
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1116 at risk

Adverse event: Hematoma PG pocket (= 30d post implant)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 1116 at risk

Adverse event: Hemodynamic instability DFT testing Procedure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1116 at risk

Adverse event: Hemorrhage - Unrelated (non study) procedure or device
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1116 at risk

Adverse event: Hypertension - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Hypertension/Hypertensive Crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1116 at risk

Adverse event: Hypotension - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1116 at risk

Adverse event: Hypotension/Orthostatic Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1116 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Inadequate healing of incision site Subject
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Inadvertent arrhythmia Procedure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1116 at risk

Adverse event: Inappropriate tachy therapy NSC (Cardiac oversensing) Electrode
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1116 at risk

Adverse event: Inappropriate tachy therapy NSR (Cardiac oversensing) System
Serious: yes
Organ System: Product Issues
Frequency: 4 affected / 1116 at risk

Adverse event: Inappropriate tachy therapy noise (Non-cardiac) System
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1116 at risk

Adverse event: Inappropriate therapy SVT above programmed rate zone System
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1116 at risk

Adverse event: Inappropriate therapy SVT discrimination error System
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 1116 at risk

Adverse event: Incisional/Superficial infection (= 30d post implant without explant)
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1116 at risk

Adverse event: Incisional/Superficial infection (>30d post implant without explant)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1116 at risk

Adverse event: Integumentary
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 1116 at risk

Adverse event: Intermittent ST elevation during implant
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1116 at risk

Adverse event: Bundle branch block left
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 1116 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1116 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1116 at risk

Adverse event: Multi-system failure
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 1116 at risk

Adverse event: Multi-system failure - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 1116 at risk

Adverse event: Multiple heart failure symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 91 affected / 1116 at risk

Adverse event: Multiple symptoms
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1116 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 1116 at risk

Adverse event: Myocardial biopsy (dilated cardiomyopathy of unknown origin)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 1116 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 14 affected / 1116 at risk

Adverse event: Non VT/VF cardiac oversensing AF
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 1116 at risk

Adverse event: Out of Range shock impedance Electrode
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1116 at risk

Adverse event: Oversensing System
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1116 at risk

Adverse event: PG erosion
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1116 at risk

Adverse event: PG migration Subject
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Patient fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1116 at risk

Adverse event: Peripheral edema - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 1116 at risk

Adverse event: Physical trauma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 1116 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Positioning during procedure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1116 at risk

Adverse event: Post-surgical wound discomfort PG site (= 30d post implant) Procedure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 1116 at risk

Adverse event: Post-surgical wound discomfort PG site (> 30d post implant)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1116 at risk

Adverse event: Postoperative urinary retention
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1116 at risk

Adverse event: Premature Ventricular Contractions (PVC)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Premature cell battery depletion - PG
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 1116 at risk

Adverse event: Psychological
Serious: yes
Organ System: Psychiatric disorders
Frequency: 6 affected / 1116 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 1116 at risk

Adverse event: Pulmonary Embolism (PE)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Pulmonary edema - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 1116 at risk

Adverse event: Pulseless Electrical Activity (PEA)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1116 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 20 affected / 1116 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1116 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Strep infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1116 at risk

Adverse event: Sub-optimal electrode position
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1116 at risk

Adverse event: Suboptimal electrode position
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1116 at risk

Adverse event: Suspected infection Incisional/Superficial (= 30d post implant)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1116 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 1116 at risk

Adverse event: Syncope - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1116 at risk

Adverse event: Systemic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 1116 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 1116 at risk

Adverse event: Unable to convert VT/VF with S-ICD
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 1116 at risk

Adverse event: Valvular damage/Valvular insufficiency
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Ventricular Fibrillation (VF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1116 at risk

Adverse event: Ventricular Tachycardia (VT)/Monomorphic VT
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 1116 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Weight gain - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1116 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1116 at risk

Adverse event: AF during conversion testing
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1116 at risk

Adverse event: Abnormal laboratory values
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Acute blood loss
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1116 at risk

Adverse event: Adverse reaction - General
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Adverse reaction HF symptoms Procedure
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1116 at risk

Adverse event: Adverse reaction Hypotension Procedure
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1116 at risk

Adverse event: Adverse reaction Medication/Anaphylactic shock Procedure
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1116 at risk

Adverse event: Adverse reaction Respiratory Procedure
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1116 at risk

Adverse event: Aortic stenosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Atrial Fibrillation (AF)
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1116 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Chest pain - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 21 affected / 1116 at risk

Adverse event: Chest pain - Ischemic
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Chest pain - Other
Serious: no
Organ System: General disorders
Frequency: 6 affected / 1116 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Dehydration - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Device system discomfort (> 30d post implant)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 1116 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 1116 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Dyspnea - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1116 at risk

Adverse event: Electrode migration/revision
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1116 at risk

Adverse event: Electrode movement Procedure
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1116 at risk

Adverse event: Electrode suture discomfort
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1116 at risk

Adverse event: Fatigue/Weakness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Genitourinary
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Hematoma Electrode incision (= 30d post implant)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1116 at risk

Adverse event: Hematoma PG pocket (= 30d post implant)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 1116 at risk

Adverse event: Inadequate healing of incision site Subject
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1116 at risk

Adverse event: Inadvertent arrhythmia Procedure
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 1116 at risk

Adverse event: Inappropriate tachy therapy NSC (Cardiac oversensing) Electrode
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 1116 at risk

Adverse event: Inappropriate tachy therapy NSR (Cardiac oversensing) System
Serious: no
Organ System: Product Issues
Frequency: 16 affected / 1116 at risk

Adverse event: Inappropriate tachy therapy noise (Non-Cardiac) PG
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1116 at risk

Adverse event: Inappropriate tachy therapy noise (Non-cardiac) System
Serious: no
Organ System: Product Issues
Frequency: 12 affected / 1116 at risk

Adverse event: Inappropriate therapy Baseline shift PG
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1116 at risk

Adverse event: Inappropriate therapy Baseline shift System
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1116 at risk

Adverse event: Inappropriate therapy SVT above programmed rate zone System
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 1116 at risk

Adverse event: Inappropriate therapy SVT discrimination error System
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 1116 at risk

Adverse event: Incisional/Superficial infection (= 30d post implant without explant)
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 1116 at risk

Adverse event: Incisional/Superficial infection (>30d post implant without explant)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1116 at risk

Adverse event: Incomplete header/electrode connection
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1116 at risk

Adverse event: Integumentary
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Intermittent sensing/undersensing System
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1116 at risk

Adverse event: Multiple heart failure symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1116 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Non VT/VF cardiac oversensing
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 1116 at risk

Adverse event: Non VT/VF cardiac oversensing AF
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1116 at risk

Adverse event: Non VT/VF cardiac oversensing for AF
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1116 at risk

Adverse event: Outcome of elective MV and LAA closure surgery
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1116 at risk

Adverse event: Oversensing System
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1116 at risk

Adverse event: PG erosion (= 30d post implant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1116 at risk

Adverse event: PG movement
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Physical trauma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1116 at risk

Adverse event: Physical trauma Procedure
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1116 at risk

Adverse event: Post-surgical bleeding/hemorrhage (= 30d post implant)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1116 at risk

Adverse event: Post-surgical wound discomfort PG site (= 30d post implant) Procedure
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 20 affected / 1116 at risk

Adverse event: Post-surgical wound discomfort PG site (> 30d post implant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 1116 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Pulmonary edema - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Random component failure Therapy available System
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1116 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Scar Cyst/Keloid Procedure
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1116 at risk

Adverse event: Seroma PG pocket (= 30d post implant)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1116 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Suspected infection Incision/Superficial (>30d post implant)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1116 at risk

Adverse event: Suspected infection Incisional/Superficial (= 30d post implant)
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 1116 at risk

Adverse event: Suture revision
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Syncope related to VT/VF Subject
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Systemic infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1116 at risk

Adverse event: T-wave oversensing
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1116 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Unable to convert VT/VF with S-ICD
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1116 at risk

Adverse event: User error programmer
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1116 at risk

Adverse event: VT/VF below programming rate
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1116 at risk

Adverse event: Ventricular Tachycardia (VT)/Monomorphic VT
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 1116 at risk

Adverse event: Vomiting during anesthesia induction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1116 at risk