Study: NCT01772576

Adverse event: Inappropriate tachy therapy - SVT
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 164 at risk

Adverse event: Inappropriate tachy therapy - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 164 at risk

Adverse event: Erosion
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 164 at risk

Adverse event: Infection (> 30 days post-implant)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 164 at risk

Adverse event: Psychological effect due to device therapy
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 164 at risk

Adverse event: Post-surgical wound discomfort
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 164 at risk

Adverse event: Post-surgical pocket hemorrhage
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 164 at risk

Adverse event: Adverse reaction - General
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 164 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 164 at risk

Adverse event: Hematoma - Pocket (<=30 days post-implant)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 164 at risk

Adverse event: Unable to capture - RV
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 164 at risk

Adverse event: Elevated threshold - RV
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 164 at risk

Adverse event: Impedance > 2000 ohms - RV
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 164 at risk

Adverse event: Dislodgment - Multiple signs - RV
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 164 at risk

Adverse event: Dislodgment - No reported signs - RV
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 164 at risk

Adverse event: Elevated threshold - LV
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 164 at risk

Adverse event: Dislodgment - Elevated threshold - LV
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 164 at risk

Adverse event: Dislodgment - No reported signs - LV
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 164 at risk

Adverse event: Pneumothorax - Procedure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 164 at risk

Adverse event: Coronary venous dissection
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 164 at risk

Adverse event: Other - Lead - Procedure: implant failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 164 at risk

Adverse event: Pulseless electrical activity (PEA)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

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

Adverse event: Ventricular fibrillation (VF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 167 at risk

Adverse event: Ventricular tachycardia (VT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 167 at risk

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

Adverse event: Atrial fibrillation (AF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 167 at risk

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

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

Adverse event: Premature ventricular contractions (PVC)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

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

Adverse event: Chest pain - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 167 at risk

Adverse event: Dyspnea - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 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: 3 affected / 167 at risk

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

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

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

Adverse event: Multiple heart failure symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 167 at risk

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

Adverse event: Coronary artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 167 at risk

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

Adverse event: Syncope
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 167 at risk

Adverse event: Chest pain - Ischemic
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 167 at risk

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

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 167 at risk

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

Adverse event: Cerebrovascular accident (CVA)
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 167 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 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: 1 affected / 167 at risk

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

Adverse event: Physical trauma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 167 at risk

Adverse event: Abnormal laboratory values
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 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: 11 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: 4 affected / 167 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 167 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 167 at risk

Adverse event: Psychological
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 167 at risk

Adverse event: Integumentary
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 167 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 167 at risk

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

Adverse event: Neoplasm malignant
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 167 at risk

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

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

Adverse event: Unable to capture - RA
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 164 at risk

Adverse event: Inappropriate tachy therapy - Other
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 164 at risk

Adverse event: Post-surgical wound discomfort
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 164 at risk

Adverse event: Post-surgical infection (<= 30 days post-implant)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 164 at risk

Adverse event: Adverse reaction - General
Serious: no
Organ System: General disorders
Frequency: 3 affected / 167 at risk

Adverse event: Adverse reaction - Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 164 at risk

Adverse event: Chest pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 164 at risk

Adverse event: Hematoma - Pocket (<=30 days post-implant)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 164 at risk

Adverse event: Other-PG system-Procedure: Other non system related
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 164 at risk

Adverse event: Dislodgment - Multiple signs - RV
Serious: no
Organ System: General disorders
Frequency: 1 affected / 164 at risk

Adverse event: Unable to capture - LV
Serious: no
Organ System: General disorders
Frequency: 1 affected / 164 at risk

Adverse event: Elevated threshold - LV
Serious: no
Organ System: General disorders
Frequency: 3 affected / 164 at risk

Adverse event: Extracardiac stimulation - LV
Serious: no
Organ System: General disorders
Frequency: 4 affected / 164 at risk

Adverse event: Dislodgment - Elevated threshold - LV
Serious: no
Organ System: General disorders
Frequency: 1 affected / 164 at risk

Adverse event: Pneumothorax - Procedure
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 164 at risk

Adverse event: Other - Lead - Procedure: difficulties due to venous access
Serious: no
Organ System: General disorders
Frequency: 1 affected / 164 at risk

Adverse event: wound infection after LV lead placement
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 164 at risk

Adverse event: Ventricular tachycardia (VT)
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 167 at risk

Adverse event: Nonsustained ventricular tachycardia (NSVT)
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 167 at risk

Adverse event: ATRIAL TACHYARRHYTHMIAS
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 167 at risk

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

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Other SVT (AVRT, AVNRT, EAT etc.)
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: Peripheral edema - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

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

Adverse event: Multiple heart failure symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 167 at risk

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

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

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

Adverse event: Chest pain - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 167 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Deep vein thrombosis (DVT)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 167 at risk

Adverse event: Localised infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 167 at risk

Adverse event: Physical trauma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 167 at risk

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

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 167 at risk

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

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 167 at risk

Adverse event: Genitourinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 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: 5 affected / 167 at risk

Adverse event: Psychological
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 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: Infections and infestations
Frequency: 2 affected / 167 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 4 affected / 167 at risk

Adverse event: Immune
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 167 at risk

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

Adverse event: Adverse drug reaction
Serious: no
Organ System: General disorders
Frequency: 3 affected / 167 at risk