Study: NCT01983293

Adverse event: Bleeding/Hematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 62 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 62 at risk

Adverse event: Lead Dislodgement Or Migration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 62 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 62 at risk

Adverse event: Atrial Or Ventricular Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 62 at risk

Adverse event: Bleeding/Hematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 62 at risk

Adverse event: Elevated Pacing Thresholds
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 62 at risk

Adverse event: Device capturing issue
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 62 at risk

Adverse event: Oversensing
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 62 at risk

Adverse event: Phrenic Nerve/Diaphragmatic Stimulation
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 62 at risk

Adverse event: Rise In Threshold And Exit Block
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 62 at risk

Adverse event: Undersensing
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 62 at risk

Adverse event: Other: Back Pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 62 at risk

Adverse event: Other: Device Insertion Site Pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 62 at risk

Adverse event: Other: Device Site Numbness
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 62 at risk

Adverse event: Other: Device Site Pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 62 at risk

Adverse event: Other: Device Site Redness
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 62 at risk

Adverse event: Other: Dysphagia And Dysguesia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 62 at risk

Adverse event: Other: Left Shoulder Pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 62 at risk

Adverse event: Other: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 62 at risk

Adverse event: Other: Swelling
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 62 at risk

Adverse event: Other: Worsening Heart Failure Due To Crt
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 62 at risk

Adverse event: Lead Dislodgement Or Migration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 128 at risk

Adverse event: Atrial Or Ventricular Arrhythmia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 128 at risk

Adverse event: Cardiac perforation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 128 at risk

Adverse event: Cardiac vein dissection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 128 at risk

Adverse event: Lead Fracture
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 128 at risk

Adverse event: Therapy For Non-Ventricular Rhythm
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 128 at risk

Adverse event: Atrial Or Ventricular Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 128 at risk

Adverse event: Bleeding/Hematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 128 at risk

Adverse event: Elevated Pacing Thresholds
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 128 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 128 at risk

Adverse event: Local Tissue Reaction; Formation Of Fibrotic Tissue
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 128 at risk

Adverse event: Device capturing issue
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 128 at risk

Adverse event: Oversensing
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 128 at risk

Adverse event: Phrenic Nerve/Diaphragmatic Stimulation
Serious: no
Organ System: Product Issues
Frequency: 5 affected / 128 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 128 at risk

Adverse event: Rise In Threshold And Exit Block
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 128 at risk

Adverse event: Undersensing
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 128 at risk

Adverse event: Other: Decompensated Systolic Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 128 at risk

Adverse event: Other: Desaturation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 128 at risk

Adverse event: Other: Device Insertion Site Pain (Intermittent)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 128 at risk

Adverse event: Other: Device Reset To Back Up Vvi
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 128 at risk

Adverse event: Other: Device Site Burning (Intermittent)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 128 at risk

Adverse event: Other: Device Site Pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 128 at risk

Adverse event: Other: Diaphragm Stimulation While Lying Supine
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 128 at risk

Adverse event: Other: Dysphagia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 128 at risk

Adverse event: Other: Elevated Lv Capture Threshold
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 128 at risk

Adverse event: Other: Itching
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 128 at risk

Adverse event: Other: Left Clavicle Pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 128 at risk

Adverse event: Other: Left Shoulder Discomfort
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 128 at risk

Adverse event: Other: Left Upper Extremity Edema
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 128 at risk

Adverse event: Other: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 128 at risk

Adverse event: Other: Pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 128 at risk

Adverse event: Other: Respiratory Insufficiency
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 128 at risk