Study: NCT02548455

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 499 at risk

Adverse event: Cardiac vein dissection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 499 at risk

Adverse event: Cardiac vein perforation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Excessive Bleeding
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 499 at risk

Adverse event: Hematoma/Seroma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Induced Arrhythmias Atrial/Ventricular
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 499 at risk

Adverse event: Infections
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 499 at risk

Adverse event: Lead dislodgement
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 20 affected / 499 at risk

Adverse event: Lead dislodgement
Serious: yes
Organ System: Product Issues
Frequency: 14 affected / 499 at risk

Adverse event: Loss of Pacing/Sensing
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 499 at risk

Adverse event: Pectoral/Diaphragmatic Stimulation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 499 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 499 at risk

Adverse event: Rise in Threshold
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Rise in Threshold
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 499 at risk

Adverse event: Anesthesia Complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Device pacing issue
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Guide Wire Problem
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Device fastener issue
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Respiratory disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 499 at risk

Adverse event: Upper Extremity Deep Vein Thrombosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 499 at risk

Adverse event: Cardiac/Coronary Sinus Dissection
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 499 at risk

Adverse event: Cardiac/Coronary Sinus Perforation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Hematoma/Seroma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 499 at risk

Adverse event: Induced Atrial or Ventricular Arrythmias
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Infection
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Lead dislodgement
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 499 at risk

Adverse event: Lead dislodgement
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 499 at risk

Adverse event: Local Tissue Reaction; Formation of Fibrotic Tissue
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 499 at risk

Adverse event: Pectoral/Diaphramatic/Phrenic Nerve Stimulation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 20 affected / 499 at risk

Adverse event: Pectoral/Diaphramatic/Phrenic Nerve Stimulation
Serious: no
Organ System: Product Issues
Frequency: 10 affected / 499 at risk

Adverse event: Oversensing
Serious: no
Organ System: General disorders
Frequency: 2 affected / 499 at risk

Adverse event: Upper Extremity Discomfort
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Oversensing
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Should Pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Suture Sleeve Disruption
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 499 at risk

Adverse event: Upper Extremity Deep Vein Thrombosis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 499 at risk

Adverse event: Device Reset Mode
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 499 at risk

Adverse event: Elevated Threshold
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 499 at risk

Adverse event: Oversensing
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 499 at risk