Study: NCT01596595

Adverse event: Other - PG System
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 1820 at risk

Adverse event: Elevated Threshold - RV
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1820 at risk

Adverse event: Inappropriate Tachy Therapy - SVT
Serious: yes
Organ System: Product Issues
Frequency: 30 affected / 1820 at risk

Adverse event: Inappropriate Tachy Therapy - Other
Serious: yes
Organ System: Product Issues
Frequency: 6 affected / 1820 at risk

Adverse event: Early ERI - Premature Declaration
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1820 at risk

Adverse event: Pacemaker Mediated Tachycardia (PMT)
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 1820 at risk

Adverse event: Erosion
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 1820 at risk

Adverse event: Infection (> 30 days post implant)
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 1820 at risk

Adverse event: Hematoma- Pocket (>30 days post implant)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1820 at risk

Adverse event: Migration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1820 at risk

Adverse event: Post Surgical wound discomfort/bruising/swelling
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1820 at risk

Adverse event: Post-surgical pocket hemorrhage/bleeding/drainage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1820 at risk

Adverse event: Post -Surgical infection (≤ 30 days post implant)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1820 at risk

Adverse event: Adverse Reaction - Respiratory
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1820 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 1820 at risk

Adverse event: Hematoma - pocket (≤ 30 days post-implant)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 1820 at risk

Adverse event: Thromboembolic events
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 1820 at risk

Adverse event: Procedure - PG System - Other
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1820 at risk

Adverse event: Dislodgement - Unable to Capture - RA
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1820 at risk

Adverse event: Dislodgement - Multiple signs- RA
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1820 at risk

Adverse event: Dislodgement - No reported signs - RA
Serious: yes
Organ System: Product Issues
Frequency: 4 affected / 1820 at risk

Adverse event: Other Lead Related
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 1820 at risk

Adverse event: Oversensing - RV
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1820 at risk

Adverse event: Unable to Capture - RV
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 1820 at risk

Adverse event: Elevated Threshold - RV 2140 - Extracardiac Stimulation - RV
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 1820 at risk

Adverse event: Extracardiac Stimulation - RV
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1820 at risk

Adverse event: Insulation Breach - RV
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 1820 at risk

Adverse event: Myocardial Perforation post implant- RV
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 1820 at risk

Adverse event: Low Out of Range Impedance - RV
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1820 at risk

Adverse event: Dislodgement - Unable to capture - RV
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 1820 at risk

Adverse event: Dislodgement - Elevated threshold - RV
Serious: yes
Organ System: Product Issues
Frequency: 4 affected / 1820 at risk

Adverse event: Dislodgement - Extracardiac stimulation - RV
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1820 at risk

Adverse event: Dislodgement - Multiple signs - RV
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1820 at risk

Adverse event: Dislodgement - No reported signs - RV
Serious: yes
Organ System: Product Issues
Frequency: 4 affected / 1820 at risk

Adverse event: Unable to Capture - LV
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1820 at risk

Adverse event: Extracardiac Stimulation - LV
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 1820 at risk

Adverse event: Conductor Coil Fracture - LV
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1820 at risk

Adverse event: Insulation Breach - LV
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1820 at risk

Adverse event: Dislodgement - Unable to Capture - LV
Serious: yes
Organ System: Product Issues
Frequency: 4 affected / 1820 at risk

Adverse event: Dislodgement - Elevated threshold - LV
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1820 at risk

Adverse event: Dislodgement - Extracardiac stimulation - LV
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1820 at risk

Adverse event: Dislodgement - Multiple signs - LV
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1820 at risk

Adverse event: Dislodgement - No reported signs - LV
Serious: yes
Organ System: Product Issues
Frequency: 7 affected / 1820 at risk

Adverse event: Inappropriate tachy therapy - SVT
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 1820 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 1820 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1820 at risk

Adverse event: Myocardial perforation without tamponade
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1820 at risk

Adverse event: Myocardial perforation with tamponade
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1820 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1820 at risk

Adverse event: Procedure - Lead - Other
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1820 at risk

Adverse event: 3rd Degree AV Block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1820 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1820 at risk

Adverse event: Pulseless Electrical Activity (PEA)
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 1820 at risk

Adverse event: Ventricular Fibrillation (VF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 29 affected / 1820 at risk

Adverse event: Ventricular Tachycardia (VT)/Monomorphic VT
Serious: yes
Organ System: Cardiac disorders
Frequency: 72 affected / 1820 at risk

Adverse event: Torsade de pointes
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1820 at risk

Adverse event: Nonsustained ventricular tachycardia (NSVT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 1820 at risk

Adverse event: Atrial Fibrillation (AF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 83 affected / 1820 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 1820 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1820 at risk

Adverse event: Atrial Tachycardia/Other SVT (e.g. AVRT, AVNRT, EAT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 1820 at risk

Adverse event: Premature Ventricular Contractions (PVC)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1820 at risk

Adverse event: Syncope - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1820 at risk

Adverse event: Dizziness - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1820 at risk

Adverse event: Chest Pain - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 1820 at risk

Adverse event: Dyspnea - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 108 affected / 1820 at risk

Adverse event: Peripheral edema - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 1820 at risk

Adverse event: Pulmonary Edema - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 1820 at risk

Adverse event: Fatigue - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1820 at risk

Adverse event: Renal Failure/Insufficiency - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 1820 at risk

Adverse event: Dehydration - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1820 at risk

Adverse event: Gastrointestinal - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1820 at risk

Adverse event: Hypotension - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1820 at risk

Adverse event: Weight Gain - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 1820 at risk

Adverse event: Heart Failure Symptoms - Unspecified
Serious: yes
Organ System: Cardiac disorders
Frequency: 142 affected / 1820 at risk

Adverse event: Multiple Heart Failure Symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 185 affected / 1820 at risk

Adverse event: Hypertension - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1820 at risk

Adverse event: Heart Failure Patient Condition - Cardiovascular - OTHER
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 1820 at risk

Adverse event: Multi-system Failure - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 1820 at risk

Adverse event: Hypotension/Orthostatic Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 37 affected / 1820 at risk

Adverse event: Hypertension/Hypertensive Crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 11 affected / 1820 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 20 affected / 1820 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 41 affected / 1820 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Vascular disorders
Frequency: 62 affected / 1820 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 38 affected / 1820 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1820 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 1820 at risk

Adverse event: Aortic valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1820 at risk

Adverse event: Mitral valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1820 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 1820 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Frequency: 37 affected / 1820 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Frequency: 23 affected / 1820 at risk

Adverse event: Chest Pain - Ischemic
Serious: yes
Organ System: Vascular disorders
Frequency: 19 affected / 1820 at risk

Adverse event: Chest Pain - Other
Serious: yes
Organ System: General disorders
Frequency: 68 affected / 1820 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 1820 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1820 at risk

Adverse event: Fatigue/Weakness
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1820 at risk

Adverse event: Multiple Symptoms
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 1820 at risk

Adverse event: Patient Condition - Cardiovascular - OTHER
Serious: yes
Organ System: Cardiac disorders
Frequency: 62 affected / 1820 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: yes
Organ System: Vascular disorders
Frequency: 25 affected / 1820 at risk

Adverse event: Cerebrovascular Accident (CVA)
Serious: yes
Organ System: Vascular disorders
Frequency: 51 affected / 1820 at risk

Adverse event: Deep Vein Thrombosis (DVT)
Serious: yes
Organ System: Vascular disorders
Frequency: 12 affected / 1820 at risk

Adverse event: Pulmonary Embolism (PE)
Serious: yes
Organ System: Vascular disorders
Frequency: 16 affected / 1820 at risk

Adverse event: Distal thromboemboli
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1820 at risk

Adverse event: Pericardial effusion - unrelated procedure/device
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1820 at risk

Adverse event: Pericarditis - unrelated procedure/device
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1820 at risk

Adverse event: Hematoma - unrelated procedure/device
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 1820 at risk

Adverse event: Hemorrhage - unrelated procedure/device
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1820 at risk

Adverse event: Patient Condition - Non-Cardiovascular - OTHER
Serious: yes
Organ System: General disorders
Frequency: 47 affected / 1820 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 38 affected / 1820 at risk

Adverse event: System Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 76 affected / 1820 at risk

Adverse event: Fever and/or Virus
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 1820 at risk

Adverse event: Physical Trauma
Serious: yes
Organ System: General disorders
Frequency: 76 affected / 1820 at risk

Adverse event: Abnormal Laboratory Values
Serious: yes
Organ System: General disorders
Frequency: 36 affected / 1820 at risk

Adverse event: Hematological
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 39 affected / 1820 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 54 affected / 1820 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 188 affected / 1820 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 183 affected / 1820 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 50 affected / 1820 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 108 affected / 1820 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 83 affected / 1820 at risk

Adverse event: Psychological
Serious: yes
Organ System: Psychiatric disorders
Frequency: 8 affected / 1820 at risk

Adverse event: Integumentary
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 39 affected / 1820 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: yes
Organ System: General disorders
Frequency: 37 affected / 1820 at risk

Adverse event: Endocrine
Serious: yes
Organ System: Endocrine disorders
Frequency: 27 affected / 1820 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 68 affected / 1820 at risk

Adverse event: Multi-System Failure
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 1820 at risk

Adverse event: Oversensing - RA
Serious: no
Organ System: Product Issues
Frequency: 8 affected / 1820 at risk

Adverse event: Unable to Capture - RA
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1820 at risk

Adverse event: Other - PG System
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1820 at risk

Adverse event: Oversensing - RV 1120 - Undersensing - RV
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 1820 at risk

Adverse event: Elevated Threshold - RV
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 1820 at risk

Adverse event: Elevated Threshold - LV
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 1820 at risk

Adverse event: Extracardiac Stimulation - LV
Serious: no
Organ System: Product Issues
Frequency: 7 affected / 1820 at risk

Adverse event: Inappropriate Tachy Therapy - SVT
Serious: no
Organ System: Product Issues
Frequency: 43 affected / 1820 at risk

Adverse event: Inappropriate Tachy Therapy - Other
Serious: no
Organ System: Product Issues
Frequency: 11 affected / 1820 at risk

Adverse event: Early ERI - Premature declaration
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1820 at risk

Adverse event: Pacemaker Mediated Tachycardia (PMT)
Serious: no
Organ System: Product Issues
Frequency: 6 affected / 1820 at risk

Adverse event: Infection (> 30 days post implant)
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 1820 at risk

Adverse event: Psychological effect due to device therapy
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 1820 at risk

Adverse event: Hematoma- Pocket (>30 days post implant)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1820 at risk

Adverse event: Seroma - Pocket (>30 days post implant)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1820 at risk

Adverse event: Migration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1820 at risk

Adverse event: Post Surgical wound discomfort/bruising/swelling
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 82 affected / 1820 at risk

Adverse event: Post-surgical pocket hemorrhage/bleeding/drainage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 1820 at risk

Adverse event: Post -Surgical infection (≤ 30 days post implant)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 1820 at risk

Adverse event: Adverse Reaction - General
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 1820 at risk

Adverse event: Adverse Reaction - Respiratory
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1820 at risk

Adverse event: Adverse Reaction - Bradycardia
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1820 at risk

Adverse event: Adverse Reaction - Hypotension
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1820 at risk

Adverse event: Inadvertent VT/VF
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1820 at risk

Adverse event: Chest pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 1820 at risk

Adverse event: Physical trauma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 1820 at risk

Adverse event: Hematoma - pocket (≤ 30 days post-implant)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 72 affected / 1820 at risk

Adverse event: Seroma - Pocket (≤ 30 days post implant)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1820 at risk

Adverse event: Thromboembolic events
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 1820 at risk

Adverse event: Procedure - PG System - Other
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 1820 at risk

Adverse event: Oversensing - RA
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 1820 at risk

Adverse event: Undersensing - RA 2032 - Unable to Capture - RA
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1820 at risk

Adverse event: Elevated Threshold - RA
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 1820 at risk

Adverse event: Extracardiac Stimulation - RA
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 1820 at risk

Adverse event: Conductor Coil Fracture - RA
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1820 at risk

Adverse event: High Out of Range Impedance - RA
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1820 at risk

Adverse event: Dislodgement - Multiple signs- RA
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1820 at risk

Adverse event: Dislodgement - No reported signs - RA
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 1820 at risk

Adverse event: Other Lead Related
Serious: no
Organ System: Product Issues
Frequency: 7 affected / 1820 at risk

Adverse event: Oversensing - RV
Serious: no
Organ System: Product Issues
Frequency: 7 affected / 1820 at risk

Adverse event: Undersensing - RV
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 1820 at risk

Adverse event: Unable to Capture - RV
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1820 at risk

Adverse event: Elevated Threshold - RV 2140 - Extracardiac Stimulation - RV
Serious: no
Organ System: Product Issues
Frequency: 12 affected / 1820 at risk

Adverse event: Extracardiac Stimulation - RV
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 1820 at risk

Adverse event: Myocardial Perforation post implant- RV
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 1820 at risk

Adverse event: Low Out of Range Impedance - RV
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 1820 at risk

Adverse event: Dislodgement - Unable to capture - RV
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 1820 at risk

Adverse event: Dislodgement - Elevated threshold - RV
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 1820 at risk

Adverse event: Dislodgement - Oversensing- RV
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1820 at risk

Adverse event: Dislodgement - Multiple signs - RV
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 1820 at risk

Adverse event: Dislodgement - No reported signs - RV
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 1820 at risk

Adverse event: Unable to Capture - LV
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 1820 at risk

Adverse event: Elevated Threshold - LV
Serious: no
Organ System: Product Issues
Frequency: 8 affected / 1820 at risk

Adverse event: Extracardiac Stimulation - LV
Serious: no
Organ System: Product Issues
Frequency: 29 affected / 1820 at risk

Adverse event: Low Out of Range Impedance - LV
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1820 at risk

Adverse event: Dislodgement - Unable to Capture - LV
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1820 at risk

Adverse event: Dislodgement - No reported signs - LV
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1820 at risk

Adverse event: Unable to Convert
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1820 at risk

Adverse event: Inappropriate tachy therapy - SVT
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1820 at risk

Adverse event: Inappropriate tachy therapy - Noise
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1820 at risk

Adverse event: Puncture site haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1820 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1820 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1820 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1820 at risk

Adverse event: Chronotropic incompetence
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1820 at risk

Adverse event: Ventricular Fibrillation (VF)
Serious: no
Organ System: Cardiac disorders
Frequency: 24 affected / 1820 at risk

Adverse event: Ventricular Tachycardia (VT)/Monomorphic VT
Serious: no
Organ System: Cardiac disorders
Frequency: 73 affected / 1820 at risk

Adverse event: Torsade de pointes
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1820 at risk

Adverse event: Nonsustained ventricular tachycardia (NSVT)
Serious: no
Organ System: Cardiac disorders
Frequency: 54 affected / 1820 at risk

Adverse event: Atrial Fibrillation (AF)
Serious: no
Organ System: Cardiac disorders
Frequency: 111 affected / 1820 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 28 affected / 1820 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 1820 at risk

Adverse event: Atrial Tachycardia/Other SVT (e.g. AVRT, AVNRT, EAT)
Serious: no
Organ System: Cardiac disorders
Frequency: 25 affected / 1820 at risk

Adverse event: Premature Ventricular Contractions (PVC)
Serious: no
Organ System: Cardiac disorders
Frequency: 17 affected / 1820 at risk

Adverse event: Syncope - Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1820 at risk

Adverse event: Dizziness - Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1820 at risk

Adverse event: Chest Pain - Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 1820 at risk

Adverse event: Dyspnea - Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 49 affected / 1820 at risk

Adverse event: Peripheral edema - Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 39 affected / 1820 at risk

Adverse event: Pulmonary Edema - Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 1820 at risk

Adverse event: Fatigue - Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 1820 at risk

Adverse event: Renal Failure/Insufficiency - Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1820 at risk

Adverse event: Gastrointestinal - Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1820 at risk

Adverse event: Hypotension - Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1820 at risk

Adverse event: Weight Gain - Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 1820 at risk

Adverse event: Heart Failure Symptoms - Unspecified
Serious: no
Organ System: Cardiac disorders
Frequency: 37 affected / 1820 at risk

Adverse event: Multiple Heart Failure Symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 75 affected / 1820 at risk

Adverse event: Hypertension - Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1820 at risk

Adverse event: Heart Failure Patient Condition - Cardiovascular - OTHER
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1820 at risk

Adverse event: Hypotension/Orthostatic Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 65 affected / 1820 at risk

Adverse event: Hypertension/Hypertensive Crisis
Serious: no
Organ System: Vascular disorders
Frequency: 42 affected / 1820 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 1820 at risk

Adverse event: Peripheral vascular disorder
Serious: no
Organ System: Vascular disorders
Frequency: 27 affected / 1820 at risk

Adverse event: Intermittent claudication
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 1820 at risk

Adverse event: Aortic stenosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1820 at risk

Adverse event: Aortic valve incompetence
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1820 at risk

Adverse event: Mitral valve incompetence
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 1820 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Frequency: 23 affected / 1820 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 65 affected / 1820 at risk

Adverse event: Chest Pain - Ischemic
Serious: no
Organ System: Vascular disorders
Frequency: 14 affected / 1820 at risk

Adverse event: Chest Pain - Other
Serious: no
Organ System: General disorders
Frequency: 83 affected / 1820 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 41 affected / 1820 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 16 affected / 1820 at risk

Adverse event: Fatigue/Weakness
Serious: no
Organ System: General disorders
Frequency: 39 affected / 1820 at risk

Adverse event: Patient Condition - Cardiovascular - OTHER
Serious: no
Organ System: Cardiac disorders
Frequency: 32 affected / 1820 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 1820 at risk

Adverse event: Cerebrovascular Accident (CVA)
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 1820 at risk

Adverse event: Deep Vein Thrombosis (DVT)
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 1820 at risk

Adverse event: Pulmonary Embolism (PE)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1820 at risk

Adverse event: Distal thromboemboli
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 1820 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 1820 at risk

Adverse event: Pericardial effusion - unrelated procedure/device
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1820 at risk

Adverse event: Pericarditis - unrelated procedure/device
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1820 at risk

Adverse event: Hematoma - unrelated procedure/device
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 1820 at risk

Adverse event: Patient Condition - Non-Cardiovascular - OTHER
Serious: no
Organ System: General disorders
Frequency: 109 affected / 1820 at risk

Adverse event: System Infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 1820 at risk

Adverse event: Fever and/or Virus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1820 at risk

Adverse event: Physical Trauma
Serious: no
Organ System: General disorders
Frequency: 97 affected / 1820 at risk

Adverse event: Abnormal Laboratory Values
Serious: no
Organ System: General disorders
Frequency: 95 affected / 1820 at risk

Adverse event: Hematological
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 34 affected / 1820 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 67 affected / 1820 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 166 affected / 1820 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 123 affected / 1820 at risk

Adverse event: Genitourinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 95 affected / 1820 at risk

Adverse event: Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 74 affected / 1820 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 165 affected / 1820 at risk

Adverse event: Psychological
Serious: no
Organ System: Psychiatric disorders
Frequency: 29 affected / 1820 at risk

Adverse event: Integumentary
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 99 affected / 1820 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: no
Organ System: General disorders
Frequency: 185 affected / 1820 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 58 affected / 1820 at risk

Adverse event: Immune
Serious: no
Organ System: Immune system disorders
Frequency: 7 affected / 1820 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 34 affected / 1820 at risk