Study: NCT02488239

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 61 at risk

Adverse event: Other SVT
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 61 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 61 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 61 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 61 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 61 at risk

Adverse event: Pulmonary edema - heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 61 at risk

Adverse event: Heart failure symptoms - unspecified
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 61 at risk

Adverse event: Chest pain - ischemic
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 61 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 61 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 61 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 61 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 61 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 61 at risk

Adverse event: LV - elevated threshold
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 61 at risk

Adverse event: LV - extracardiac stimulation
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 61 at risk

Adverse event: Procedure - coronary venous dissection
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 61 at risk

Adverse event: RA - dislogement - elevated threshold
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 61 at risk

Adverse event: RV - dislodgement - elevated threshold
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 61 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 61 at risk

Adverse event: Device Deficiency
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 61 at risk

Adverse event: Dyspnea - Heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 61 at risk

Adverse event: Elevated threshold - RA
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 61 at risk

Adverse event: Extracardiac stimulation - LV
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 61 at risk

Adverse event: Head, eyes, ears, nose, throat (HEENT)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: Hematoma - Pocket (<= 30 days post-implant)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 61 at risk

Adverse event: Inability to maintain telemetry
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 61 at risk

Adverse event: Infection (> 30 days post-implant)
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 61 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 61 at risk

Adverse event: Other - Lead - Procedure
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 61 at risk

Adverse event: Other- Patient condition - Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 61 at risk

Adverse event: Other- Patient condition - Non- cardiovascular
Serious: no
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: Pacemaker-mediated tachycardia (PMT)
Serious: no
Organ System: Product Issues
Frequency: 10 affected / 61 at risk

Adverse event: Pneumothorax - Procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 61 at risk

Adverse event: Post-surgical wound discomfort
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 61 at risk

Adverse event: Premature atrial contractions (PAC)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 61 at risk

Adverse event: Premature ventricular contractions (PVC)
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 61 at risk

Adverse event: Syncope
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 61 at risk

Adverse event: Undersensing - RA
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 61 at risk