Study: NCT01576016

Adverse event: RA Lead Related: Lead Dislodgement or Migration
Serious: yes
Organ System: Product Issues
Frequency: 24 affected / 920 at risk

Adverse event: RA Lead Related: Elevated Pacing Thresholds
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 920 at risk

Adverse event: RA Lead Related: Cardiac Perforation
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 920 at risk

Adverse event: RA Lead Related: Lead Fracture
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 920 at risk

Adverse event: RA Lead Related: Undersensing
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 920 at risk

Adverse event: RV Lead Related: Lead Dislodgement or Migration
Serious: yes
Organ System: Product Issues
Frequency: 7 affected / 920 at risk

Adverse event: RV Lead Related: Elevated Pacing Thresholds
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 920 at risk

Adverse event: VR Lead Related: Lead Fracture
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 920 at risk

Adverse event: RV Lead Related: Loss of Capture
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 920 at risk

Adverse event: RV Lead Related: Extracardiac Stimulation
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 920 at risk

Adverse event: RV Lead Related: Twiddler's Syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 920 at risk

Adverse event: Pacemaker Related: Device Connectivity Issue
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 920 at risk

Adverse event: Pacemaker Related: Early Battery Depletion
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 920 at risk

Adverse event: System Related: Cardiac Tamponade
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 920 at risk

Adverse event: System Related: Decompensated HF
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 920 at risk

Adverse event: System Related: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 920 at risk

Adverse event: System Related: Pacemaker Induced Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 920 at risk

Adverse event: System Related: Cardiac Perforation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 920 at risk

Adverse event: System Related: Pacemaker system relocation to right side
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 920 at risk

Adverse event: System Related: Pericardial Effusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 920 at risk

Adverse event: Procedure Related: Pneumothorax
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 920 at risk

Adverse event: Procedure Related: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 920 at risk

Adverse event: Procedure Related: Bleeding/Hematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 920 at risk

Adverse event: Procedure Related: Pocket Site/Incision Pain Lasting Greater Than 72 Hours Post Implant
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 920 at risk

Adverse event: Procedure Related: Insufficient Slack in Lead
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 920 at risk

Adverse event: Procedure Related: Device Migration
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 920 at risk

Adverse event: Procedure Related: Hemoptysis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 920 at risk

Adverse event: Procedure Related: Hemothorax
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 920 at risk

Adverse event: Procedure Related: Pericardial Effusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 920 at risk

Adverse event: Procedure Related: Stenosis of The Left Subclavian Vein
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 920 at risk

Adverse event: Procedure Related: Thrombo-Embolic Event
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 920 at risk

Adverse event: Procedure Related: Wound Dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 920 at risk

Adverse event: RA Lead Related: Oversensing
Serious: no
Organ System: Product Issues
Frequency: 7 affected / 920 at risk

Adverse event: Pacemaker Related: Pacemaker Mediated Tachycardia
Serious: no
Organ System: General disorders
Frequency: 30 affected / 920 at risk

Adverse event: Procedure Related: Bleeding/Hematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 920 at risk

Adverse event: Procedure Related: Pneumothorax
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 920 at risk

Adverse event: Procedure Related: Thrombo-Embolic Event
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 920 at risk

Adverse event: ORE: Atrial Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 46 affected / 920 at risk

Adverse event: ORE: Decompensated HF
Serious: no
Organ System: Cardiac disorders
Frequency: 17 affected / 920 at risk

Adverse event: ORE: Ventricular Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 920 at risk

Adverse event: ORE: Chest Pain
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 920 at risk

Adverse event: ORE: Cerebrovascular Accident
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 920 at risk

Adverse event: ORE: Angina
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 920 at risk

Adverse event: ORE: Syncope
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 920 at risk

Adverse event: Pacemaker Related: Pacemaker Mediated Tachycardia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 255 at risk