Study: NCT01856491

Adverse event: Inappropriate tachy therapy - SVT
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Erosion
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 167 at risk

Adverse event: Infection (> 30 days post-implant)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 167 at risk

Adverse event: Psychological effect due to device therapy
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 167 at risk

Adverse event: Post-surgical wound discomfort
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 167 at risk

Adverse event: Post-surgical infection (<= 30 days post-implant)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 167 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Hematoma - Pocket (<=30 days post-implant)
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 167 at risk

Adverse event: Conductor coil fracture - RA
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 167 at risk

Adverse event: Elevated threshold - RV
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 167 at risk

Adverse event: Dislodgment - Unable to capture - LV
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 167 at risk

Adverse event: Pneumothorax - Procedure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 167 at risk

Adverse event: Ventricular fibrillation (VF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 167 at risk

Adverse event: Ventricular tachycardia (VT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 167 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 167 at risk

Adverse event: Other SVT (AVRT, AVNRT, EAT etc.)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Chest pain - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 167 at risk

Adverse event: Dyspnea - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 167 at risk

Adverse event: Peripheral edema - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Pulmonary edema - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 167 at risk

Adverse event: Heart failure symptoms - Unspecified
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 167 at risk

Adverse event: Multiple heart failure symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 167 at risk

Adverse event: Multi-system failure - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 167 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 167 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 167 at risk

Adverse event: RELATED TO ISCHEMIA
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 167 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 167 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 167 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 167 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 167 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 167 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 167 at risk

Adverse event: Chest pain - Ischemic
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Chest pain - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 167 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 167 at risk

Adverse event: Cerebrovascular accident (CVA)
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 167 at risk

Adverse event: Pulmonary embolism (PE)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 167 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 167 at risk

Adverse event: Hematoma - Unrelated to procedure or device
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 167 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 167 at risk

Adverse event: Systemic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 167 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 167 at risk

Adverse event: Physical trauma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 167 at risk

Adverse event: Abnormal laboratory values
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 167 at risk

Adverse event: Hematological
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 167 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 167 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 167 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 167 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 167 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 167 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 167 at risk

Adverse event: Integumentary
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 167 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 167 at risk

Adverse event: Endocrine
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 167 at risk

Adverse event: Multi-system failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 167 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 167 at risk

Adverse event: Not yet classified
Serious: no
Organ System: General disorders
Frequency: 3 affected / 167 at risk

Adverse event: Inappropriate tachy therapy - SVT
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 167 at risk

Adverse event: Inappropriate tachy therapy - Other
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Post-surgical wound discomfort
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 167 at risk

Adverse event: Inadvertent VT/VF
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 167 at risk

Adverse event: Hematoma - Pocket (<=30 days post-implant)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 167 at risk

Adverse event: Elevated threshold - RA
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Elevated threshold - RV
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Coronary venous dissection
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 167 at risk

Adverse event: Ventricular fibrillation (VF)
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 167 at risk

Adverse event: Ventricular tachycardia (VT)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Atrial fibrillation (AF)
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 167 at risk

Adverse event: Other SVT (AVRT, AVNRT, EAT etc.)
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 167 at risk

Adverse event: Syncope - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Chest pain - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Dyspnea - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 167 at risk

Adverse event: Multiple heart failure symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Hypertension - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Chest pain - Ischemic
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Chest pain - Other
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 167 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 167 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 167 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 167 at risk

Adverse event: Physical trauma
Serious: no
Organ System: General disorders
Frequency: 6 affected / 167 at risk

Adverse event: Hematological
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 167 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 167 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 167 at risk

Adverse event: Genitourinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 167 at risk

Adverse event: Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 167 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 167 at risk

Adverse event: Psychological
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 167 at risk

Adverse event: Integumentary
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 167 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: no
Organ System: General disorders
Frequency: 10 affected / 167 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 167 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: General disorders
Frequency: 2 affected / 167 at risk

Adverse event: medication side effect
Serious: no
Organ System: General disorders
Frequency: 1 affected / 167 at risk

Adverse event: pain in device pocket
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 167 at risk