Study: NCT01781078

Adverse event: Early ERI - Random component failure
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 229 at risk

Adverse event: Erosion
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 229 at risk

Adverse event: Infection (> 30 days post-implant)
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 229 at risk

Adverse event: Impedance > 2000 ohms - RA
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 229 at risk

Adverse event: Dislodgment - RA
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 229 at risk

Adverse event: Other - RA Lead
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 229 at risk

Adverse event: Elevated threshold - RV
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 229 at risk

Adverse event: Myocardial perforation post-implant - RV
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 229 at risk

Adverse event: Impedance > 2000 ohms - RV
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 229 at risk

Adverse event: Dislodgment - RV
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 229 at risk

Adverse event: Adverse reaction - General
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 229 at risk

Adverse event: Physical trauma
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 229 at risk

Adverse event: Myocardial perforation without tamponade
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 229 at risk

Adverse event: Myocardial perforation with tamponade
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 229 at risk

Adverse event: Venous occlusion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 229 at risk

Adverse event: Adverse reaction - General
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 229 at risk

Adverse event: Dyspnea - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 229 at risk

Adverse event: Pulmonary edema - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 229 at risk

Adverse event: Heart failure symptoms - Unspecified
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 229 at risk

Adverse event: Multiple heart failure symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 229 at risk

Adverse event: Other - Heart failure patient condition
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 229 at risk

Adverse event: 3rd degree AV block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 229 at risk

Adverse event: Ventricular fibrillation (VF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 229 at risk

Adverse event: Ventricular tachycardia (VT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 229 at risk

Adverse event: Nonsustained ventricular tachycardia (NSVT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 229 at risk

Adverse event: Atrial fibrillation (AF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 229 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 229 at risk

Adverse event: Other SVT (AVRT, AVNRT, EAT etc.)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 229 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 229 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 229 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 229 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 229 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 229 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 229 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 229 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 229 at risk

Adverse event: Chest pain - Ischemic
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 229 at risk

Adverse event: Chest pain - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 229 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 229 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 229 at risk

Adverse event: Multiple symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 229 at risk

Adverse event: Transient ischemic attack (TIA)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 229 at risk

Adverse event: Cerebrovascular accident (CVA)
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 229 at risk

Adverse event: Deep vein thrombosis (DVT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 229 at risk

Adverse event: Pulmonary embolism (PE)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 229 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 229 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 229 at risk

Adverse event: Other - Patient condition
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 229 at risk

Adverse event: Other - Patient condition
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 229 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 229 at risk

Adverse event: Systemic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 229 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 229 at risk

Adverse event: Physical trauma
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 229 at risk

Adverse event: Abnormal laboratory values
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 229 at risk

Adverse event: Hematological
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 229 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 229 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 229 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 229 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 8 affected / 229 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 9 affected / 229 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 229 at risk

Adverse event: Psychological
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 229 at risk

Adverse event: Integumentary
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 229 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 229 at risk

Adverse event: Endocrine
Serious: yes
Organ System: Endocrine disorders
Frequency: 6 affected / 229 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 10 affected / 229 at risk

Adverse event: Multi-system failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 229 at risk

Adverse event: AV Block Intermittent
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 229 at risk

Adverse event: Oversensing - RA
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 229 at risk

Adverse event: Undersensing - RA
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 229 at risk

Adverse event: Other - PG system
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 229 at risk

Adverse event: Rate response inappropriate
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 229 at risk

Adverse event: Inappropriate AV delay
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 229 at risk

Adverse event: Pacemaker-mediated tachycardia (PMT)
Serious: no
Organ System: Product Issues
Frequency: 6 affected / 229 at risk

Adverse event: Oversensing - RA
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 229 at risk

Adverse event: Undersensing - RA
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 229 at risk

Adverse event: Extracardiac stimulation - RA
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 229 at risk

Adverse event: Dislodgment - RA
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 229 at risk

Adverse event: Oversensing - RV
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 229 at risk

Adverse event: Undersensing - RV
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 229 at risk

Adverse event: Elevated threshold - RV
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 229 at risk

Adverse event: Extracardiac stimulation - RV
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 229 at risk

Adverse event: Post-surgical wound discomfort
Serious: no
Organ System: Surgical and medical procedures
Frequency: 5 affected / 229 at risk

Adverse event: Post-surgical pocket hemorrhage
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 229 at risk

Adverse event: Post-surgical infection (<= 30 days post-implant)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 229 at risk

Adverse event: Chest pain
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 229 at risk

Adverse event: Hematoma - Pocket (<=30 days post-implant)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 229 at risk

Adverse event: Puncture site hematoma - Procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 229 at risk

Adverse event: Pneumothorax - Procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 229 at risk

Adverse event: Venous occlusion
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 229 at risk

Adverse event: Protocol Testing - Adverse reaction - General
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 229 at risk

Adverse event: Other - Protocol Testing
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 229 at risk

Adverse event: Dyspnea - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 229 at risk

Adverse event: Hypotension - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 229 at risk

Adverse event: Heart failure symptoms - Unspecified
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 229 at risk

Adverse event: Multiple heart failure symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 229 at risk

Adverse event: Other - Heart failure patient condition
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 229 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 229 at risk

Adverse event: Chronotropic incompetence
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 229 at risk

Adverse event: Ventricular tachycardia (VT)
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 229 at risk

Adverse event: Nonsustained ventricular tachycardia (NSVT)
Serious: no
Organ System: Cardiac disorders
Frequency: 26 affected / 229 at risk

Adverse event: Atrial fibrillation (AF)
Serious: no
Organ System: Cardiac disorders
Frequency: 32 affected / 229 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 229 at risk

Adverse event: Other SVT (AVRT, AVNRT, EAT etc.)
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 229 at risk

Adverse event: Premature ventricular contractions (PVC)
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 229 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 229 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 229 at risk

Adverse event: Peripheral vascular disorder
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 229 at risk

Adverse event: Aortic stenosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 229 at risk

Adverse event: Mitral valve incompetence
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 229 at risk

Adverse event: Syncope
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 229 at risk

Adverse event: Dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 16 affected / 229 at risk

Adverse event: Chest pain - Ischemic
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 229 at risk

Adverse event: Chest pain - Other
Serious: no
Organ System: Cardiac disorders
Frequency: 18 affected / 229 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 229 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 229 at risk

Adverse event: Fatigue
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 229 at risk

Adverse event: Multiple symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 229 at risk

Adverse event: Cerebrovascular accident (CVA)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 229 at risk

Adverse event: Deep vein thrombosis (DVT)
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 229 at risk

Adverse event: Distal thromboemboli
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 229 at risk

Adverse event: Hematoma - Unrelated to procedure or device
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 229 at risk

Adverse event: Other - Patient condition
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 229 at risk

Adverse event: Other - Patient condition
Serious: no
Organ System: General disorders
Frequency: 6 affected / 229 at risk

Adverse event: Systemic infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 229 at risk

Adverse event: Physical trauma
Serious: no
Organ System: General disorders
Frequency: 26 affected / 229 at risk

Adverse event: Abnormal laboratory values
Serious: no
Organ System: General disorders
Frequency: 6 affected / 229 at risk

Adverse event: Hematological
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 229 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 229 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 229 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 229 at risk

Adverse event: Genitourinary
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 14 affected / 229 at risk

Adverse event: Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 229 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 27 affected / 229 at risk

Adverse event: Psychological
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 229 at risk

Adverse event: Integumentary
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 229 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: no
Organ System: General disorders
Frequency: 36 affected / 229 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 229 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 229 at risk

Adverse event: AV Block Intermittent
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 229 at risk

Adverse event: Dislodgment - RA
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 118 at risk

Adverse event: Other - RA Lead
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 118 at risk

Adverse event: Myocardial perforation post-implant - RV
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 118 at risk

Adverse event: Dislodgment - RV
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 118 at risk

Adverse event: Post-surgical infection (<= 30 days post-implant)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 118 at risk

Adverse event: Myocardial perforation without tamponade
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 118 at risk

Adverse event: Myocardial perforation with tamponade
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 118 at risk

Adverse event: Dyspnea - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 118 at risk

Adverse event: Fatigue - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 118 at risk

Adverse event: Heart failure symptoms - Unspecified
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 118 at risk

Adverse event: Multiple heart failure symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 118 at risk

Adverse event: Hypertension - Heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 118 at risk

Adverse event: Other - Heart failure patient condition
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 118 at risk

Adverse event: Torsades des pointes
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 118 at risk

Adverse event: Nonsustained ventricular tachycardia (NSVT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 118 at risk

Adverse event: Atrial fibrillation (AF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 118 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 118 at risk

Adverse event: Other SVT (AVRT, AVNRT, EAT etc.)
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 118 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 118 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 118 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 118 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 118 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 118 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 118 at risk

Adverse event: Chest pain - Ischemic
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 118 at risk

Adverse event: Chest pain - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 118 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 118 at risk

Adverse event: Multiple symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 118 at risk

Adverse event: Transient ischemic attack (TIA)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 118 at risk

Adverse event: Cerebrovascular accident (CVA)
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 118 at risk

Adverse event: Deep vein thrombosis (DVT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 118 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 118 at risk

Adverse event: Other - Patient condition
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 118 at risk

Adverse event: Systemic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 118 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 118 at risk

Adverse event: Physical trauma
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 118 at risk

Adverse event: Hematological
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 118 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 118 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 118 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 118 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 118 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 118 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 118 at risk

Adverse event: Psychological
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 118 at risk

Adverse event: Integumentary
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 118 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 118 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 118 at risk

Adverse event: Adverse Reaction - Allergic
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 118 at risk

Adverse event: Undersensing - RA
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 118 at risk

Adverse event: Other - PG system
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 118 at risk

Adverse event: Oversensing - RV
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 118 at risk

Adverse event: Inappropriate AV delay
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 118 at risk

Adverse event: Pacemaker-mediated tachycardia (PMT)
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 118 at risk

Adverse event: Hematoma - Pocket (> 30 days post-implant)
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 118 at risk

Adverse event: Undersensing - RA
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 118 at risk

Adverse event: Other - RA Lead
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 118 at risk

Adverse event: Extracardiac stimulation - RV
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 118 at risk

Adverse event: Post-surgical wound discomfort
Serious: no
Organ System: Surgical and medical procedures
Frequency: 5 affected / 118 at risk

Adverse event: Post-surgical pocket hemorrhage
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 118 at risk

Adverse event: Post-surgical infection (<= 30 days post-implant)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 118 at risk

Adverse event: Chest pain
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 118 at risk

Adverse event: Hematoma - Pocket (<=30 days post-implant)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 118 at risk

Adverse event: Myocardial perforation without tamponade
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 118 at risk

Adverse event: Other - PG system procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 118 at risk

Adverse event: Peripheral edema - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 118 at risk

Adverse event: Pulmonary edema - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 118 at risk

Adverse event: Heart failure symptoms - Unspecified
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 118 at risk

Adverse event: Multiple heart failure symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 118 at risk

Adverse event: Other - Heart failure patient condition
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 118 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 118 at risk

Adverse event: Chronotropic incompetence
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 118 at risk

Adverse event: Nonsustained ventricular tachycardia (NSVT)
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 118 at risk

Adverse event: Atrial fibrillation (AF)
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 118 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 118 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 118 at risk

Adverse event: Other SVT (AVRT, AVNRT, EAT etc.)
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 118 at risk

Adverse event: Premature ventricular contractions (PVC)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 118 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 118 at risk

Adverse event: Aortic stenosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 118 at risk

Adverse event: Syncope
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 118 at risk

Adverse event: Dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 118 at risk

Adverse event: Chest pain - Other
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 118 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 118 at risk

Adverse event: Fatigue
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 118 at risk

Adverse event: Multiple symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 118 at risk

Adverse event: Pericardial effusion - Unrelated to procedure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 118 at risk

Adverse event: Other - Patient condition
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 118 at risk

Adverse event: Other - Patient condition
Serious: no
Organ System: General disorders
Frequency: 6 affected / 118 at risk

Adverse event: Physical trauma
Serious: no
Organ System: General disorders
Frequency: 7 affected / 118 at risk

Adverse event: Abnormal laboratory values
Serious: no
Organ System: General disorders
Frequency: 3 affected / 118 at risk

Adverse event: Hematological
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 118 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 118 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 118 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 118 at risk

Adverse event: Genitourinary
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 14 affected / 118 at risk

Adverse event: Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 118 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 22 affected / 118 at risk

Adverse event: Psychological
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 118 at risk

Adverse event: Integumentary
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 118 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: no
Organ System: General disorders
Frequency: 20 affected / 118 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 118 at risk

Adverse event: Extracardiac stimulation - LV
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 118 at risk

Adverse event: Adverse Reaction - Allergic
Serious: no
Organ System: General disorders
Frequency: 11 affected / 118 at risk