Study: NCT02469623

Adverse event: Access site Injury
Serious: yes
Organ System: Surgical and medical procedures
Notes: Hematoma right groin. Resolved without treatment. Remained in hospital for observation
Frequency: 1 affected / 85 at risk

Adverse event: Ablation re-do requiring hospitalization
Serious: yes
Organ System: Surgical and medical procedures
Notes: Atrial Fibrillation ablation Re-do
Frequency: 1 affected / 85 at risk

Adverse event: Valve Dysfunction
Serious: yes
Organ System: Surgical and medical procedures
Notes: Worsening of mitral valve regurgitation
Frequency: 1 affected / 85 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Patient was hospitalized due to acute renal insufficiency with anuria, hyperkalemia and signs of systemic infection of unknown etiology.
Frequency: 1 affected / 85 at risk

Adverse event: Carcinomamammae sin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Pt undergone the surgical resection on 18/NOV/2016 and was discharged from hospital on 22-Nov-2016. Recent check confirmed that marker tumors are normal.
Frequency: 1 affected / 85 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Cardiac disorders
Notes: Progressive shortness of breath secondary to noted heart failure
Frequency: 1 affected / 85 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: On 09-MAY-2016 the pacemaker was implanted due to poly-arrhythmia symptoms and due to bradycardia.
Frequency: 1 affected / 85 at risk

Adverse event: Brain neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Patient was experiencing memory loss. The patient was assessed, CT head performed, followed by an MRI of the head. Diagnosis of glioblastoma multiforme
Frequency: 1 affected / 85 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac Arrest
Frequency: 1 affected / 85 at risk

Adverse event: Abnormal Thyroid Function
Serious: yes
Organ System: Endocrine disorders
Notes: Post ablation admitted with abnormal thyroid function labs. Amiodarone stopped
Frequency: 1 affected / 85 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Patient thought to have developed chest infection. Antibiotics started and discharged 18 May 2016
Frequency: 1 affected / 85 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Patient went into fast AF rate 160, this lasted 3-4 hours. The event returned, and the patient was treated at another hospital and pacemaker was inserted on the 3rd August 2016
Frequency: 1 affected / 85 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Notes: Patient presented to emergency room in flutter. He was given 500mcg x 2 Digoxin and this terminated the flutter into AF. He was discharged the following day.
Frequency: 1 affected / 85 at risk

Adverse event: Electrocardiogram abnormal
Serious: no
Organ System: Cardiac disorders
Notes: Right bundle branch block
Frequency: 1 affected / 85 at risk

Adverse event: Abnormal lab value/infection
Serious: no
Organ System: Infections and infestations
Notes: Leukocytosis as noted by changes in lab values. Controlled by primary care Doctor.
Frequency: 1 affected / 85 at risk

Adverse event: Access site injury
Serious: no
Organ System: Surgical and medical procedures
Notes: groin hematoma
Frequency: 14 affected / 85 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Notes: AF recurrence with dyspnea and fatigue
Frequency: 1 affected / 85 at risk

Adverse event: Air embolism/ST change
Serious: no
Organ System: Surgical and medical procedures
Notes: An apparent air embolism from the AcQGuide Sheath caused a brief (1-2 min) change in ST segment that resolved without treatment
Frequency: 1 affected / 85 at risk

Adverse event: Upper limb fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Broken neck of the Humerus
Frequency: 1 affected / 85 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Notes: Patient described retrosternal chest pain. Echocardiogram shows no pericardial effusion. Mild analgesics prescribed
Frequency: 1 affected / 85 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Rivaroxaban stopped - Apixaban started due to Diarrhea
Frequency: 1 affected / 85 at risk

Adverse event: Dizziness and Syncope
Serious: no
Organ System: Cardiac disorders
Notes: Then patient complains of feeling frequently dizzy and as though he will pass out. ECG today shows sinus rhythm at 49bpm. No treatment prescribed
Frequency: 1 affected / 85 at risk

Adverse event: Dyspnoea exertional
Serious: no
Organ System: Cardiac disorders
Notes: Dyspnea on Exertion. Sotolol discontinued
Frequency: 1 affected / 85 at risk

Adverse event: Haematoma
Serious: no
Organ System: Surgical and medical procedures
Notes: Groin Hematoma
Frequency: 4 affected / 85 at risk

Adverse event: Hemorrhoid Bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Hemorrhage from Hemorrhoid
Frequency: 1 affected / 85 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: Hypertension
Frequency: 2 affected / 85 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Infection
Frequency: 1 affected / 85 at risk

Adverse event: Lower Extremity Swelling
Serious: no
Organ System: General disorders
Notes: Swelling of Lower Extremities
Frequency: 1 affected / 85 at risk

Adverse event: Pericarditis
Serious: no
Organ System: Cardiac disorders
Notes: Patient developed pericarditis 48 hr. post procedure, resolved with NSAIDS.
Frequency: 1 affected / 85 at risk

Adverse event: Pleuritic Chest pain
Serious: no
Organ System: Cardiac disorders
Notes: Patient suffered pleuritic chest pain post procedure. Negative work up and mild analgesics prescribed.
Frequency: 1 affected / 85 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Cardiac disorders
Notes: By 7 days FU, patient mentioned shortness of breath. Negative chest work up. Abnormal labs for thyroid function noted. AAD medication changed
Frequency: 1 affected / 85 at risk

Adverse event: Stumble/Fall
Serious: no
Organ System: General disorders
Notes: Stumble fall on the street
Frequency: 1 affected / 85 at risk

Adverse event: Swollen Legs
Serious: no
Organ System: General disorders
Notes: Swollen Legs. Amlodipine discontinued
Frequency: 1 affected / 85 at risk

Adverse event: Symptomatic Palpitations
Serious: no
Organ System: Cardiac disorders
Notes: Palpitations and extra systolic beats
Frequency: 1 affected / 85 at risk

Adverse event: Syncope
Serious: no
Organ System: Cardiac disorders
Notes: Syncopal episodes
Frequency: 1 affected / 85 at risk

Adverse event: Tonsilitis
Serious: no
Organ System: Endocrine disorders
Notes: Tonsilitis
Frequency: 1 affected / 85 at risk

Adverse event: Vertigo
Serious: no
Organ System: General disorders
Notes: Patient feels dizzy and had a hematoma in the right eye. 24 hours post-procedure diagnosed with recurrent AF
Frequency: 1 affected / 85 at risk