Study: NCT00800384

Adverse event: PG System
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1247 at risk

Adverse event: Unable to convert - Defibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1247 at risk

Adverse event: PG system - Therapy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Inappropriate tachy therapy - SVT
Serious: yes
Organ System: Cardiac disorders
Frequency: 25 affected / 1247 at risk

Adverse event: Inappropriate tachy therapy - NSR
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1247 at risk

Adverse event: Inappropriate tachy therapy - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1247 at risk

Adverse event: Early ERI - Random component failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1247 at risk

Adverse event: Early ERI - Premature declaration
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1247 at risk

Adverse event: Pacemaker-mediated tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1247 at risk

Adverse event: Erosion
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 1247 at risk

Adverse event: PG system - Infection (> 30 days post implant)
Serious: yes
Organ System: Infections and infestations
Frequency: 24 affected / 1247 at risk

Adverse event: Psychological effect due to device therapy
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 1247 at risk

Adverse event: Post-surgical wound discomfort
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 7 affected / 1247 at risk

Adverse event: Post-surgical infection (<= 30 days post-implant)
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 1247 at risk

Adverse event: Adverse reaction - General
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1247 at risk

Adverse event: Adverse reaction - Hypotension
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1247 at risk

Adverse event: Inadvertent VT/VF
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1247 at risk

Adverse event: Inadvertent SVT
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1247 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1247 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1247 at risk

Adverse event: Hematoma - Pocket (<=30 days post-implant)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 23 affected / 1247 at risk

Adverse event: Thromboembolic events
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 6 affected / 1247 at risk

Adverse event: Unable to capture - RA
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1247 at risk

Adverse event: Elevated threshold - RA
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Conductor coil fracture - RA
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Dislodgment - Multiple signs - RA
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1247 at risk

Adverse event: Dislodgment - No reported signs - RA
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 1247 at risk

Adverse event: Other - Lead
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1247 at risk

Adverse event: RV - unspecific
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Oversensing - RV
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1247 at risk

Adverse event: Unable to capture - RV
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 1247 at risk

Adverse event: Elevated threshold - RV
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 1247 at risk

Adverse event: Electrode damaged - RV
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1247 at risk

Adverse event: Dislodgment - Elevated threshold -RV
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 1247 at risk

Adverse event: Dislodgment - Oversensing - RV
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Dislodgment - Multiple signs - RV
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1247 at risk

Adverse event: Dislodgment - No reported signs - RV
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 1247 at risk

Adverse event: Unable to capture - LV
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1247 at risk

Adverse event: Elevated threshold - LV
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1247 at risk

Adverse event: Extracardiac stimulation - LV
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1247 at risk

Adverse event: Dislodgment - Unable to capture - LV
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Dislodgment - Elevated threshold - LV
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Dislodgment - Multiple signs - LV
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Dislodgment - No reported signs -LV
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1247 at risk

Adverse event: Oversensing - Defibrillation lead
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1247 at risk

Adverse event: Undersensing - Defibrillation lead
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1247 at risk

Adverse event: Elevated DFT - Defibrillation lead
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Pneumothorax - Procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 19 affected / 1247 at risk

Adverse event: Renal failure due to contrast media - Procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1247 at risk

Adverse event: Pleural effusion - Procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1247 at risk

Adverse event: Coronary venous dissection
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1247 at risk

Adverse event: Myocardial perforation with tamponade
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1247 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 7 affected / 1247 at risk

Adverse event: Other - Lead - Procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 18 affected / 1247 at risk

Adverse event: Patient CONDITION Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: 1st degree AV block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Pulseless electrical activity (PEA)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1247 at risk

Adverse event: Ventricular tachyarrhythmias - unspecified
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 1247 at risk

Adverse event: Ventricular fibrillation (VF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 1247 at risk

Adverse event: Ventricular tachycardia (VT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 49 affected / 1247 at risk

Adverse event: Electrical Storm
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 1247 at risk

Adverse event: Nonsustained ventricular tachycardia (NSVT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1247 at risk

Adverse event: Atrial Tachyarrhythmias - unspecific
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 1247 at risk

Adverse event: Atrial fibrillation (AF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 42 affected / 1247 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 1247 at risk

Adverse event: Other SVT (eg AVRT, AVNRT, EAT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1247 at risk

Adverse event: Premature ventricular contractions (PVC)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1247 at risk

Adverse event: Syncope - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1247 at risk

Adverse event: Dizziness - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Chest pain - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 1247 at risk

Adverse event: Dyspnea - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 42 affected / 1247 at risk

Adverse event: Peripheral edema - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 1247 at risk

Adverse event: Pulmonary edema - Heart failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 1247 at risk

Adverse event: Fatigue - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Renal insufficiency - Heart failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 9 affected / 1247 at risk

Adverse event: Dehydration - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1247 at risk

Adverse event: Gastrointestinal - Heart failure
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Heart failure symptoms - Unspecified
Serious: yes
Organ System: Cardiac disorders
Frequency: 37 affected / 1247 at risk

Adverse event: Multiple heart failure symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 145 affected / 1247 at risk

Adverse event: Hypertension - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1247 at risk

Adverse event: Other- Heart failure patient condition - Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 1247 at risk

Adverse event: Multi-system failure - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 76 affected / 1247 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 1247 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 1247 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1247 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 1247 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 34 affected / 1247 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 83 affected / 1247 at risk

Adverse event: Vascular disease - unspecific
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 1247 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 36 affected / 1247 at risk

Adverse event: Valve related - unspecific
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 1247 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1247 at risk

Adverse event: Mitral valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1247 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 26 affected / 1247 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 1247 at risk

Adverse event: Chest pain - Ischemic
Serious: yes
Organ System: Cardiac disorders
Frequency: 20 affected / 1247 at risk

Adverse event: Chest pain - Other
Serious: yes
Organ System: General disorders
Frequency: 22 affected / 1247 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 1247 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1247 at risk

Adverse event: Other- Patient condition - Cardiovascular
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Transient ischemic attack (TIA)
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 1247 at risk

Adverse event: Cerebrovascular accident (CVA)
Serious: yes
Organ System: Vascular disorders
Frequency: 33 affected / 1247 at risk

Adverse event: Deep vein thrombosis (DVT)
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1247 at risk

Adverse event: Pulmonary embolism (PE)
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 1247 at risk

Adverse event: Distal thromboemboli
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 1247 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Procedure related complication other than implant procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 16 affected / 1247 at risk

Adverse event: Pericardial effusion - Unrelated to procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1247 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 9 affected / 1247 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 6 affected / 1247 at risk

Adverse event: Adverse reaction - Allergic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 1247 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 1247 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 1247 at risk

Adverse event: WHOLE BODY
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Death - Reason unspecified
Serious: yes
Organ System: General disorders
Frequency: 46 affected / 1247 at risk

Adverse event: Systemic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 46 affected / 1247 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 1247 at risk

Adverse event: Physical trauma
Serious: yes
Organ System: General disorders
Frequency: 29 affected / 1247 at risk

Adverse event: Abnormal laboratory values
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 1247 at risk

Adverse event: Hematological
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 1247 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 15 affected / 1247 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 95 affected / 1247 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 94 affected / 1247 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 26 affected / 1247 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 54 affected / 1247 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 41 affected / 1247 at risk

Adverse event: Psychological
Serious: yes
Organ System: Psychiatric disorders
Frequency: 11 affected / 1247 at risk

Adverse event: Integumentary
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 1247 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: yes
Organ System: General disorders
Frequency: 31 affected / 1247 at risk

Adverse event: Endocrine
Serious: yes
Organ System: Endocrine disorders
Frequency: 25 affected / 1247 at risk

Adverse event: Immune
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 1247 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 61 affected / 1247 at risk

Adverse event: Multi-system failure
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 1247 at risk

Adverse event: N/A
Serious: yes
Organ System: General disorders
Frequency: 13 affected / 1247 at risk

Adverse event: Adverse drug reaction
Serious: yes
Organ System: General disorders
Frequency: 14 affected / 1247 at risk

Adverse event: PG System
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Oversensing - RA
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Other - PG system
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1247 at risk

Adverse event: Unable to convert - Defibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: PG system - Therapy
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Inappropriate AV Delay
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Inappropriate tachy therapy - SVT
Serious: no
Organ System: Cardiac disorders
Frequency: 20 affected / 1247 at risk

Adverse event: Inappropriate tachy therapy - NSR
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 1247 at risk

Adverse event: Inappropriate tachy therapy - Other
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 1247 at risk

Adverse event: Early ERI - Premature declaration
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Pacemaker-mediated tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 1247 at risk

Adverse event: PG system - Diagnosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: PG System - Patient related
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 1247 at risk

Adverse event: PG system - Infection (> 30 days post implant)
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 1247 at risk

Adverse event: Psychological effect due to device therapy
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 1247 at risk

Adverse event: Hematoma - Pocket (> 30 days post implant)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1247 at risk

Adverse event: Post-surgical wound discomfort
Serious: no
Organ System: Surgical and medical procedures
Frequency: 20 affected / 1247 at risk

Adverse event: Post-surgical pocket hemorrhage
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1247 at risk

Adverse event: Post-surgical infection (<= 30 days post-implant)
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 1247 at risk

Adverse event: Adverse reaction - General
Serious: no
Organ System: General disorders
Frequency: 6 affected / 1247 at risk

Adverse event: Adverse reaction - Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Adverse reaction - Hypotension
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 1247 at risk

Adverse event: Vasovagal
Serious: no
Organ System: Surgical and medical procedures
Frequency: 5 affected / 1247 at risk

Adverse event: Inadvertent VT/VF
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Inadvertent SVT
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 1247 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1247 at risk

Adverse event: Physical trauma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 6 affected / 1247 at risk

Adverse event: Hematoma - Pocket (<=30 days post-implant)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 60 affected / 1247 at risk

Adverse event: Seroma - Pocket (<=30 days post-implant)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 1247 at risk

Adverse event: Thromboembolic events
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 1247 at risk

Adverse event: Other - PG system - Procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1247 at risk

Adverse event: Oversensing - RA
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1247 at risk

Adverse event: Undersensing - RA
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Unable to capture - RA
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Elevated threshold - RA
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 1247 at risk

Adverse event: Electrode damaged - RA
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Impedance > 2000 ohms - RA
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Dislodgment - Elevated threshold - RA
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Dislodgment - Multiple signs - RA
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Dislodgment - No reported signs - RA
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Other - Lead
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 1247 at risk

Adverse event: Oversensing - RV
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1247 at risk

Adverse event: Elevated threshold - RV
Serious: no
Organ System: Cardiac disorders
Frequency: 16 affected / 1247 at risk

Adverse event: Impedance < 300 ohms - RV
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Dislodgment - No reported signs - RV
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Unable to capture - LV
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 1247 at risk

Adverse event: Elevated threshold - LV
Serious: no
Organ System: Cardiac disorders
Frequency: 19 affected / 1247 at risk

Adverse event: Extracardiac stimulation - LV
Serious: no
Organ System: Cardiac disorders
Frequency: 32 affected / 1247 at risk

Adverse event: Dislodgment - Multiple signs - LV
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Dislodgment - No reported signs -LV
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1247 at risk

Adverse event: Defibrillation lead
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Oversensing - Defibrillation lead
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1247 at risk

Adverse event: Elevated DFT - Defibrillation lead
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1247 at risk

Adverse event: Arterial perforation - Procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1247 at risk

Adverse event: Pneumothorax - Procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1247 at risk

Adverse event: Renal failure due to contrast media - Procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1247 at risk

Adverse event: Pleural effusion - Procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 1247 at risk

Adverse event: Coronary venous dissection
Serious: no
Organ System: Surgical and medical procedures
Frequency: 8 affected / 1247 at risk

Adverse event: AV block (transient) - Procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 1247 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1247 at risk

Adverse event: Other - Lead - Procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 23 affected / 1247 at risk

Adverse event: Patient CONDITION Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Bradyarrhythmias - unspecific
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1247 at risk

Adverse event: 1st degree AV block
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1247 at risk

Adverse event: 2nd degree AV block
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1247 at risk

Adverse event: 3rd degree AV block
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1247 at risk

Adverse event: Chronotropic incompetence
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1247 at risk

Adverse event: Ventricular tachyarrhythmias - unspecified
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1247 at risk

Adverse event: Ventricular fibrillation (VF)
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1247 at risk

Adverse event: Ventricular tachycardia (VT)
Serious: no
Organ System: Cardiac disorders
Frequency: 23 affected / 1247 at risk

Adverse event: Nonsustained ventricular tachycardia (NSVT)
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 1247 at risk

Adverse event: Accelerated idiopathic rhythm
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Atrial Tachyarrhythmias - unspecific
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 1247 at risk

Adverse event: Atrial fibrillation (AF)
Serious: no
Organ System: Cardiac disorders
Frequency: 45 affected / 1247 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 1247 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Other SVT (eg AVRT, AVNRT, EAT)
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 1247 at risk

Adverse event: Premature ventricular contractions (PVC)
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 1247 at risk

Adverse event: Syncope - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1247 at risk

Adverse event: Dizziness - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 1247 at risk

Adverse event: Chest pain - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Dyspnea - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 34 affected / 1247 at risk

Adverse event: Peripheral edema - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 1247 at risk

Adverse event: Pulmonary edema - Heart failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 1247 at risk

Adverse event: Fatigue - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 1247 at risk

Adverse event: Renal insufficiency - Heart failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 1247 at risk

Adverse event: Dehydration - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1247 at risk

Adverse event: Weight gain - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Heart failure symptoms - Unspecified
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 1247 at risk

Adverse event: Multiple heart failure symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 31 affected / 1247 at risk

Adverse event: Hypertension - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1247 at risk

Adverse event: Other- Heart failure patient condition - Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 1247 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 22 affected / 1247 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 1247 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Vascular disorders
Frequency: 18 affected / 1247 at risk

Adverse event: Vascular disease - unspecific
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 1247 at risk

Adverse event: Peripheral vascular disorder
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 1247 at risk

Adverse event: Valve related - unspecific
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1247 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Frequency: 43 affected / 1247 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 26 affected / 1247 at risk

Adverse event: Chest pain - Ischemic
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 1247 at risk

Adverse event: Chest pain - Other
Serious: no
Organ System: General disorders
Frequency: 17 affected / 1247 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: General disorders
Frequency: 19 affected / 1247 at risk

Adverse event: Palpitations
Serious: no
Organ System: General disorders
Frequency: 12 affected / 1247 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 10 affected / 1247 at risk

Adverse event: Multiple Symptoms
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1247 at risk

Adverse event: Thromboembolic events - unspecific
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 1247 at risk

Adverse event: Transient ischemic attack (TIA)
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 1247 at risk

Adverse event: Distal thromboemboli
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 1247 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1247 at risk

Adverse event: Procedure related complication other than implant procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 7 affected / 1247 at risk

Adverse event: Pericardial effusion - Unrelated to procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1247 at risk

Adverse event: Pericarditis
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1247 at risk

Adverse event: Haematoma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 5 affected / 1247 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1247 at risk

Adverse event: Adverse reaction - Allergic reaction
Serious: no
Organ System: Immune system disorders
Frequency: 6 affected / 1247 at risk

Adverse event: Presyncope
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 1247 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 1247 at risk

Adverse event: Systemic infection
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 1247 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 1247 at risk

Adverse event: Physical trauma
Serious: no
Organ System: General disorders
Frequency: 41 affected / 1247 at risk

Adverse event: Abnormal laboratory values
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 1247 at risk

Adverse event: Hematological
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 1247 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 1247 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 49 affected / 1247 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 48 affected / 1247 at risk

Adverse event: Genitourinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 38 affected / 1247 at risk

Adverse event: Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 20 affected / 1247 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 51 affected / 1247 at risk

Adverse event: Psychological
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 1247 at risk

Adverse event: Integumentary
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 30 affected / 1247 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: no
Organ System: General disorders
Frequency: 53 affected / 1247 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 41 affected / 1247 at risk

Adverse event: Immune
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 1247 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 14 affected / 1247 at risk

Adverse event: N/A
Serious: no
Organ System: General disorders
Frequency: 16 affected / 1247 at risk

Adverse event: Adverse drug reaction
Serious: no
Organ System: General disorders
Frequency: 26 affected / 1247 at risk

Adverse event: N/A
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1247 at risk

Adverse event: PG System
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Unable to capture - RV
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Unable to convert - Defibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 1253 at risk

Adverse event: Elevated DFT - Defibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1253 at risk

Adverse event: PG system - Therapy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Inappropriate tachy therapy - SVT
Serious: yes
Organ System: Cardiac disorders
Frequency: 25 affected / 1253 at risk

Adverse event: Inappropriate tachy therapy - NSR
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Inappropriate tachy therapy - Noise
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Early ERI - Consistent with device programming
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Early ERI - Premature declaration
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1253 at risk

Adverse event: PG System - Patient related
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Erosion
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 1253 at risk

Adverse event: PG system - Infection (> 30 days post implant)
Serious: yes
Organ System: Infections and infestations
Frequency: 21 affected / 1253 at risk

Adverse event: Psychological effect due to device therapy
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Seroma - Pocket (> 30 days post- implant)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1253 at risk

Adverse event: Migration
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Post-surgical wound discomfort
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1253 at risk

Adverse event: Post-surgical pocket hemorrhage
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 1253 at risk

Adverse event: Post-surgical infection (<= 30 days post-implant)
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 1253 at risk

Adverse event: Adverse reaction - General
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 1253 at risk

Adverse event: Adverse reaction - Respiratory
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 6 affected / 1253 at risk

Adverse event: Adverse reaction - Hypotension
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1253 at risk

Adverse event: Hemodynamic instability - DFT testing
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1253 at risk

Adverse event: Inadvertent VT/VF
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 1253 at risk

Adverse event: Inadvertent SVT
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 1253 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 1253 at risk

Adverse event: Physical trauma
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1253 at risk

Adverse event: Hematoma - Pocket (<=30 days post-implant)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 31 affected / 1253 at risk

Adverse event: Seroma - Pocket (<=30 days post-implant)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1253 at risk

Adverse event: Thromboembolic events
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 10 affected / 1253 at risk

Adverse event: Other - PG system - Procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1253 at risk

Adverse event: Undersensing - RA
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Elevated threshold - RA
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Dislodgment - Unable to capture - RA
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Dislodgment - Extracardiac stimulation- RA
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Dislodgment - Multiple signs - RA
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Dislodgment - No reported signs - RA
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 1253 at risk

Adverse event: Other - Lead
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1253 at risk

Adverse event: RV - unspecific
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Unable to capture - RV
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Elevated threshold - RV
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 1253 at risk

Adverse event: Conductor coil fracture - RV
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Insulation breach - RV
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1253 at risk

Adverse event: Electrode damaged - RV
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Myocardial perforation post- implant - RV
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Impedance < 300 ohms - RV
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Impedance > 2000 ohms - RV
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Dislodgment - Unable to capture RV
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Dislodgment - Elevated threshold -RV
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Dislodgment - Multiple signs - RV
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Dislodgment - No reported signs - RV
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 1253 at risk

Adverse event: Unable to capture - LV
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Elevated threshold - LV
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Extracardiac stimulation - LV
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1253 at risk

Adverse event: Electrode damaged - LV
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Dislodgment - Unable to capture - LV
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Dislodgment - Extracardiac stimulation- LV
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Dislodgment - Multiple signs - LV
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Dislodgment - No reported signs -LV
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1253 at risk

Adverse event: Oversensing - Defibrillation lead
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Undersensing - Defibrillation lead
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Elevated DFT - Defibrillation lead
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Puncture site hematoma - Procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1253 at risk

Adverse event: Pneumothorax - Procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 11 affected / 1253 at risk

Adverse event: Pleural effusion - Procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1253 at risk

Adverse event: Hemothorax - Procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1253 at risk

Adverse event: Coronary venous dissection
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 1253 at risk

Adverse event: Myocardial perforation with tamponade
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1253 at risk

Adverse event: AV block (transient) - Procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1253 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 1253 at risk

Adverse event: Other - Lead - Procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 18 affected / 1253 at risk

Adverse event: Tachycardia - unspecific
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Bradyarrhythmias - unspecific
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: 1st degree AV block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: 3rd degree AV block
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Pulseless electrical activity (PEA)
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1253 at risk

Adverse event: Ventricular tachyarrhythmias - unspecified
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 1253 at risk

Adverse event: Ventricular fibrillation (VF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 1253 at risk

Adverse event: Ventricular tachycardia (VT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 38 affected / 1253 at risk

Adverse event: Electrical Storm
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 1253 at risk

Adverse event: Nonsustained ventricular tachycardia (NSVT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Ventricular flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Atrial Tachyarrhythmias - unspecific
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Atrial fibrillation (AF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 49 affected / 1253 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 17 affected / 1253 at risk

Adverse event: Other SVT (eg AVRT, AVNRT, EAT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 1253 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Premature ventricular contractions (PVC)
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1253 at risk

Adverse event: Chest pain - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Dyspnea - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 41 affected / 1253 at risk

Adverse event: Peripheral edema - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1253 at risk

Adverse event: Pulmonary edema - Heart failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 1253 at risk

Adverse event: Fatigue - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Renal insufficiency - Heart failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 1253 at risk

Adverse event: Dehydration - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1253 at risk

Adverse event: Gastrointestinal - Heart failure
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Heart failure symptoms - Unspecified
Serious: yes
Organ System: Cardiac disorders
Frequency: 42 affected / 1253 at risk

Adverse event: Multiple heart failure symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 138 affected / 1253 at risk

Adverse event: Hypertension - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Other- Heart failure patient condition - Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Multi-system failure - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 57 affected / 1253 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 1253 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 1253 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 1253 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 27 affected / 1253 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 46 affected / 1253 at risk

Adverse event: Vascular disease - unspecific
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 1253 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 37 affected / 1253 at risk

Adverse event: Valve related - unspecific
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 1253 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 1253 at risk

Adverse event: Mitral valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 37 affected / 1253 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Chest pain - Ischemic
Serious: yes
Organ System: Cardiac disorders
Frequency: 21 affected / 1253 at risk

Adverse event: Chest pain - Other
Serious: yes
Organ System: General disorders
Frequency: 19 affected / 1253 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 1253 at risk

Adverse event: Palpitations
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Other- Patient condition - Cardiovascular
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Thromboembolic events - unspecific
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Transient ischemic attack (TIA)
Serious: yes
Organ System: Vascular disorders
Frequency: 12 affected / 1253 at risk

Adverse event: Cerebrovascular accident (CVA)
Serious: yes
Organ System: Vascular disorders
Frequency: 23 affected / 1253 at risk

Adverse event: Deep vein thrombosis (DVT)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Pulmonary embolism (PE)
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 1253 at risk

Adverse event: Distal thromboemboli
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 1253 at risk

Adverse event: Procedure related complication other than implant procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 12 affected / 1253 at risk

Adverse event: Pericardial effusion - Unrelated to procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 1253 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1253 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 1253 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 1253 at risk

Adverse event: Adverse reaction - Allergic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 1253 at risk

Adverse event: Death - Reason unspecified
Serious: yes
Organ System: General disorders
Frequency: 50 affected / 1253 at risk

Adverse event: Systemic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 36 affected / 1253 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Physical trauma
Serious: yes
Organ System: General disorders
Frequency: 37 affected / 1253 at risk

Adverse event: Abnormal laboratory values
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 1253 at risk

Adverse event: Hematological
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 1253 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 18 affected / 1253 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 115 affected / 1253 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 95 affected / 1253 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 38 affected / 1253 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 41 affected / 1253 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 34 affected / 1253 at risk

Adverse event: Psychological
Serious: yes
Organ System: Psychiatric disorders
Frequency: 14 affected / 1253 at risk

Adverse event: Integumentary
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 1253 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: yes
Organ System: General disorders
Frequency: 23 affected / 1253 at risk

Adverse event: Endocrine
Serious: yes
Organ System: Endocrine disorders
Frequency: 32 affected / 1253 at risk

Adverse event: Immune
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 60 affected / 1253 at risk

Adverse event: Multi-system failure
Serious: yes
Organ System: General disorders
Frequency: 12 affected / 1253 at risk

Adverse event: N/A
Serious: yes
Organ System: General disorders
Frequency: 14 affected / 1253 at risk

Adverse event: Adverse drug reaction
Serious: yes
Organ System: General disorders
Frequency: 13 affected / 1253 at risk

Adverse event: N/A
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Unable to convert - Defibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Elevated DFT - Defibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1253 at risk

Adverse event: PG system - Therapy
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Inappropriate tachy therapy - SVT
Serious: no
Organ System: Cardiac disorders
Frequency: 22 affected / 1253 at risk

Adverse event: Inappropriate tachy therapy - NSR
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 1253 at risk

Adverse event: Inappropriate tachy therapy - Noise
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Inappropriate tachy therapy - Other
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Pacemaker-mediated tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Inability to maintain telemetry
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 1253 at risk

Adverse event: PG System - Patient related
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1253 at risk

Adverse event: PG system - Infection (> 30 days post implant)
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 1253 at risk

Adverse event: Psychological effect due to device therapy
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Migration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Post-surgical wound discomfort
Serious: no
Organ System: Surgical and medical procedures
Frequency: 21 affected / 1253 at risk

Adverse event: Post-surgical pocket hemorrhage
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1253 at risk

Adverse event: Post-surgical infection (<= 30 days post-implant)
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 1253 at risk

Adverse event: Adverse reaction - General
Serious: no
Organ System: General disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Adverse reaction - Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Adverse reaction - Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Adverse reaction - Hypotension
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 1253 at risk

Adverse event: Vasovagal
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1253 at risk

Adverse event: Hemodynamic instability - DFT testing
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1253 at risk

Adverse event: Inadvertent VT/VF
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Inadvertent SVT
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 1253 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1253 at risk

Adverse event: Physical trauma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 7 affected / 1253 at risk

Adverse event: Hematoma - Pocket (<=30 days post-implant)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 51 affected / 1253 at risk

Adverse event: Seroma - Pocket (<=30 days post-implant)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1253 at risk

Adverse event: Thromboembolic events
Serious: no
Organ System: Surgical and medical procedures
Frequency: 10 affected / 1253 at risk

Adverse event: Other - PG system - Procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1253 at risk

Adverse event: Oversensing - RA
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Undersensing - RA
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Unable to capture - RA
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Elevated threshold - RA
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 1253 at risk

Adverse event: Extracardiac stimulation - RA
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Impedance > 2000 ohms - RA
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Dislodgment - Unable to capture - RA
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Dislodgment - Extracardiac stimulation- RA
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Dislodgment - Multiple signs - RA
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Dislodgment - No reported signs - RA
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Other - Lead
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 1253 at risk

Adverse event: Oversensing - RV
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Unable to capture - RV
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Elevated threshold - RV
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 1253 at risk

Adverse event: Conductor coil fracture - RV
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Dislodgment - Elevated threshold -RV
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Dislodgment - Multiple signs - RV
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Unable to capture - LV
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Elevated threshold - LV
Serious: no
Organ System: Cardiac disorders
Frequency: 21 affected / 1253 at risk

Adverse event: Extracardiac stimulation - LV
Serious: no
Organ System: Cardiac disorders
Frequency: 36 affected / 1253 at risk

Adverse event: Electrode damaged - LV
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Dislodgment - Unable to capture - LV
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Dislodgment - Elevated threshold - LV
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Dislodgment - Multiple signs - LV
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Dislodgment - No reported signs -LV
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Defibrillation lead
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Oversensing - Defibrillation lead
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Undersensing - Defibrillation lead
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Elevated DFT - Defibrillation lead
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Pneumothorax - Procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 1253 at risk

Adverse event: Renal failure due to contrast media - Procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1253 at risk

Adverse event: Pleural effusion - Procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 1253 at risk

Adverse event: Coronary venous dissection
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 1253 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1253 at risk

Adverse event: Other - Lead - Procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 27 affected / 1253 at risk

Adverse event: Patient CONDITION Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 1253 at risk

Adverse event: Chronotropic incompetence
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Ventricular tachyarrhythmias - unspecified
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Ventricular fibrillation (VF)
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 1253 at risk

Adverse event: Ventricular tachycardia (VT)
Serious: no
Organ System: Cardiac disorders
Frequency: 33 affected / 1253 at risk

Adverse event: Nonsustained ventricular tachycardia (NSVT)
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 1253 at risk

Adverse event: Atrial Tachyarrhythmias - unspecific
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Atrial fibrillation (AF)
Serious: no
Organ System: Cardiac disorders
Frequency: 43 affected / 1253 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 1253 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Other SVT (eg AVRT, AVNRT, EAT)
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 1253 at risk

Adverse event: Premature ventricular contractions (PVC)
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 1253 at risk

Adverse event: Dizziness - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Chest pain - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 1253 at risk

Adverse event: Dyspnea - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 29 affected / 1253 at risk

Adverse event: Peripheral edema - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 1253 at risk

Adverse event: Pulmonary edema - Heart failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Fatigue - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 1253 at risk

Adverse event: Renal insufficiency - Heart failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Dehydration - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Weight gain - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Heart failure symptoms - Unspecified
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 1253 at risk

Adverse event: Multiple heart failure symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 33 affected / 1253 at risk

Adverse event: Other- Heart failure patient condition - Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 19 affected / 1253 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 15 affected / 1253 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Vascular disorders
Frequency: 14 affected / 1253 at risk

Adverse event: Vascular disease - unspecific
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 1253 at risk

Adverse event: Peripheral vascular disorder
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 1253 at risk

Adverse event: Valve related - unspecific
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Frequency: 27 affected / 1253 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 36 affected / 1253 at risk

Adverse event: Chest pain - Ischemic
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 1253 at risk

Adverse event: Chest pain - Other
Serious: no
Organ System: General disorders
Frequency: 19 affected / 1253 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: General disorders
Frequency: 12 affected / 1253 at risk

Adverse event: Palpitations
Serious: no
Organ System: General disorders
Frequency: 9 affected / 1253 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 1253 at risk

Adverse event: Multiple Symptoms
Serious: no
Organ System: General disorders
Frequency: 4 affected / 1253 at risk

Adverse event: Thromboembolic events - unspecific
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Transient ischemic attack (TIA)
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Cerebrovascular accident (CVA)
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Deep vein thrombosis (DVT)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Distal thromboemboli
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Procedure related complication other than implant procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 1253 at risk

Adverse event: Haematoma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 1253 at risk

Adverse event: Adverse reaction - Allergic reaction
Serious: no
Organ System: Immune system disorders
Frequency: 7 affected / 1253 at risk

Adverse event: Presyncope
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 1253 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 1253 at risk

Adverse event: WHOLE BODY
Serious: no
Organ System: General disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Systemic infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 1253 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Physical trauma
Serious: no
Organ System: General disorders
Frequency: 30 affected / 1253 at risk

Adverse event: Abnormal laboratory values
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 1253 at risk

Adverse event: Hematological
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 1253 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 1253 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 56 affected / 1253 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 59 affected / 1253 at risk

Adverse event: Genitourinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 28 affected / 1253 at risk

Adverse event: Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 14 affected / 1253 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 49 affected / 1253 at risk

Adverse event: Psychological
Serious: no
Organ System: Psychiatric disorders
Frequency: 14 affected / 1253 at risk

Adverse event: Integumentary
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 30 affected / 1253 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: no
Organ System: General disorders
Frequency: 49 affected / 1253 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 38 affected / 1253 at risk

Adverse event: Immune
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 13 affected / 1253 at risk

Adverse event: N/A
Serious: no
Organ System: General disorders
Frequency: 21 affected / 1253 at risk

Adverse event: Adverse drug reaction
Serious: no
Organ System: General disorders
Frequency: 25 affected / 1253 at risk