Study: NCT01179477

Adverse event: Lead Dislodgement or Migration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 62 affected / 1930 at risk

Adverse event: Diaphragmatic/Phrenic Nerve Stimulation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 16 affected / 1930 at risk

Adverse event: Device capturing issue
Serious: yes
Organ System: Product Issues
Frequency: 9 affected / 1930 at risk

Adverse event: Elevated Pacing Thresholds
Serious: yes
Organ System: Product Issues
Frequency: 8 affected / 1930 at risk

Adverse event: Abnormal LV Lead Pacing Impedance <= 200 OHMS or >= 2000 OHMS
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 1930 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1930 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1930 at risk

Adverse event: Induced Atrial or Ventricular Arrhythmias
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1930 at risk

Adverse event: Lead Fracture
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1930 at risk

Adverse event: Lead Insulation Damage
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1930 at risk

Adverse event: Pain/Discomfort At Incision Site
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1930 at risk

Adverse event: Device power source issue
Serious: yes
Organ System: Product Issues
Frequency: 8 affected / 1930 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Procedure Related
Frequency: 24 affected / 1930 at risk

Adverse event: Suspected Generator Malfunction
Serious: yes
Organ System: Product Issues
Frequency: 4 affected / 1930 at risk

Adverse event: Erosion
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1930 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1930 at risk

Adverse event: LV Lead Loss of Capture
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1930 at risk

Adverse event: Twiddler Syndrome
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 1930 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1930 at risk

Adverse event: RA Lead Dislodgement or Migration
Serious: yes
Organ System: Product Issues
Frequency: 20 affected / 1930 at risk

Adverse event: RA Abnormal Lead Impedance
Serious: yes
Organ System: Product Issues
Frequency: 4 affected / 1930 at risk

Adverse event: RA Lead Insulation Damage
Serious: yes
Organ System: Product Issues
Frequency: 4 affected / 1930 at risk

Adverse event: RA Loss of Capture
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 1930 at risk

Adverse event: RA Atrial Lead Noise
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1930 at risk

Adverse event: RA Cardiac/Coronary Sinus Perforation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1930 at risk

Adverse event: RA Diaphragmatic/Phrenic Nerve Stimulation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1930 at risk

Adverse event: RA Elevated Pacing Thresholds
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1930 at risk

Adverse event: RA Oversensing
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1930 at risk

Adverse event: RA Undersensing
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1930 at risk

Adverse event: RV Lead Dislodgement or Migration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 31 affected / 1930 at risk

Adverse event: RV Elevated Pacing Thresholds
Serious: yes
Organ System: Product Issues
Frequency: 9 affected / 1930 at risk

Adverse event: RV Lead Fracture
Serious: yes
Organ System: Product Issues
Frequency: 7 affected / 1930 at risk

Adverse event: RV Lead Insulation Damage
Serious: yes
Organ System: Product Issues
Frequency: 5 affected / 1930 at risk

Adverse event: RV Abnormal Lead Impedance
Serious: yes
Organ System: Product Issues
Frequency: 4 affected / 1930 at risk

Adverse event: RV Cardiac/Coronary Sinus Perforation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1930 at risk

Adverse event: RV Loss of Capture
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 1930 at risk

Adverse event: RV Cardiac Tamponade
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1930 at risk

Adverse event: RV Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1930 at risk

Adverse event: RV Inappropriate Shock
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1930 at risk

Adverse event: RV Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1930 at risk

Adverse event: RV Oversensing
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1930 at risk

Adverse event: RV Pectoral Stimulation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1930 at risk

Adverse event: RV Lead Unable to Defibrillate
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1930 at risk

Adverse event: RV Undersensing
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1930 at risk

Adverse event: Procedure Hematoma/Seroma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 1930 at risk

Adverse event: Procedure Pneumothorax/Hemothorax
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 1930 at risk

Adverse event: Procedural Pericardial Effusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1930 at risk

Adverse event: Procedural Cardiac/Coronary Sinus Perforation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1930 at risk

Adverse event: Procedural Cardiac Arrest
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1930 at risk

Adverse event: Procedural Cardiac Tamponade
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1930 at risk

Adverse event: Procedural Deep Vein Thrombosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1930 at risk

Adverse event: Procedural Device Migration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1930 at risk

Adverse event: Procedural Guidewire Stuck In LV Lead
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1930 at risk

Adverse event: Procedural Lead Dislodgement or Migration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1930 at risk

Adverse event: Procedural Pleural Effusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1930 at risk

Adverse event: Procedural Skin Injury At PG Pocket
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1930 at risk

Adverse event: LV Lead Elevated Pacing Thresholds
Serious: no
Organ System: Product Issues
Notes: LV Lead Related Observations
Frequency: 214 affected / 1930 at risk

Adverse event: LV Diaphragmatic/Phrenic Nerve Stimulation
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: LV Lead Related Observations
Frequency: 145 affected / 1930 at risk

Adverse event: LV Loss of Capture
Serious: no
Organ System: Product Issues
Notes: Lead Related Observations
Frequency: 19 affected / 1930 at risk

Adverse event: Abnormal LV Lead Pacing Impedance <= 200 Ω or >= 2000 Ω
Serious: no
Organ System: Product Issues
Notes: LV Lead Related Observations
Frequency: 16 affected / 1930 at risk

Adverse event: LV Induced Atrial or Ventricular Arrhythmias
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: LV Lead Related Observations
Frequency: 2 affected / 1930 at risk

Adverse event: LV Lead Dislodgement or Migration
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: LV Lead Related Observations
Frequency: 2 affected / 1930 at risk

Adverse event: LV Cardiac/Coronary Sinus Dissection
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: LV Lead Related Observations
Frequency: 1 affected / 1930 at risk

Adverse event: LV Coronary Sinus or Cardiac Vein Thrombosis
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: LV Lead Related Observations
Frequency: 1 affected / 1930 at risk

Adverse event: LV Lead Insulation Damage
Serious: no
Organ System: Product Issues
Notes: LV Lead Related Observations
Frequency: 1 affected / 1930 at risk

Adverse event: System/Pulse Generator Related Therapy For Non-Ventricular Rhythm
Serious: no
Organ System: Cardiac disorders
Notes: (System / PG / Other Leads/ Procedure)
Frequency: 23 affected / 1930 at risk

Adverse event: System/Pulse Generator Related Failed ICD Shock
Serious: no
Organ System: Product Issues
Notes: System / PG / Other Leads/ Procedure
Frequency: 1 affected / 1930 at risk

Adverse event: System/Pulse Generator Related Idioventricular Rhythm Preventing Biventricular Pacing
Serious: no
Organ System: Cardiac disorders
Notes: System / PG / Other Leads/ Procedure
Frequency: 1 affected / 1930 at risk

Adverse event: System/Pulse Generator Related Pacemaker Mediated Tachycardia
Serious: no
Organ System: Product Issues
Notes: System / PG / Other Leads/ Procedure
Frequency: 1 affected / 1930 at risk

Adverse event: RA Lead Related Oversensing
Serious: no
Organ System: Product Issues
Frequency: 9 affected / 1930 at risk

Adverse event: RA Lead Related Abnormal Lead Impedance
Serious: no
Organ System: Product Issues
Frequency: 5 affected / 1930 at risk

Adverse event: RA Lead Related Atrial Lead Noise
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 1930 at risk

Adverse event: RA Lead Related Elevated Pacing Thresholds
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 1930 at risk

Adverse event: RA Lead Related Lead Insulation Damage
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 1930 at risk

Adverse event: RA Lead Related Loss of Capture
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 1930 at risk

Adverse event: RA Lead Related Lead Dislodgement or Migration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1930 at risk

Adverse event: RA Lead Related Lead Fracture
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1930 at risk

Adverse event: RA Lead Related Myopotential Sensing
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1930 at risk

Adverse event: RA Lead Related Undersensing
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1930 at risk

Adverse event: RV Lead Related Therapy For Non-Ventricular Rhythm
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 1930 at risk

Adverse event: RV Lead Related Abnormal Lead Impedance
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 1930 at risk

Adverse event: RV Lead Related Lead Insulation Damage
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 1930 at risk

Adverse event: RV Lead Related Bilateral Pleural Effusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1930 at risk

Adverse event: RV Lead Related Elevated Pacing Thresholds
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1930 at risk

Adverse event: RV Lead Related Lead Externalization
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1930 at risk

Adverse event: RV Lead Related Myopotential Sensing
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1930 at risk

Adverse event: RV Lead Related Oversensing
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 1930 at risk

Adverse event: RV Lead Related Pectoral Stimulation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1930 at risk

Adverse event: Procedure Related Hematoma/Seroma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 33 affected / 1930 at risk

Adverse event: Procedure Related Cardiac/Coronary Sinus Dissection
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 1930 at risk

Adverse event: Procedure Related Infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 1930 at risk

Adverse event: Procedure Related Atrial Arrhythmia
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1930 at risk

Adverse event: Procedure Related Pericardial Effusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1930 at risk

Adverse event: Procedure Related Bleeding And/or Hemoptysis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1930 at risk

Adverse event: Procedure Related Cardiac Vein Thrombus
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1930 at risk

Adverse event: Procedure Related Part of The Delivery Tool Was Left In The Coronary Sinus/ Ventricle
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1930 at risk

Adverse event: Procedure Related Pneumothorax/Hemothorax
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1930 at risk

Adverse event: Procedure Related Pulmonary Edema
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1930 at risk

Adverse event: Procedure Related Renal Failure or Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1930 at risk

Adverse event: Procedure Related Acute Left Arm Thrombophlebitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1930 at risk

Adverse event: Procedure Related Cardiac/Coronary Sinus Perforation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1930 at risk

Adverse event: Procedure Related Decompensated Heart Failure
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1930 at risk

Adverse event: Procedure Related Device Incision Erythema
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1930 at risk

Adverse event: Procedure Related Excessive Bleeding
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1930 at risk

Adverse event: Procedure Related Frozen Shoulder
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1930 at risk

Adverse event: Procedure Related High DFT's
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1930 at risk

Adverse event: Procedure Related Hypotension
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1930 at risk

Adverse event: Procedure Related Hypotension Requiring Medical Intervention During CRT-D Implant
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1930 at risk

Adverse event: Procedure Related Myocardial Infarction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1930 at risk

Adverse event: Procedure Related Pericarditis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1930 at risk

Adverse event: Other Therapy For Non-Ventricular Rhythm
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 1930 at risk

Adverse event: Other Pericardial Effusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1930 at risk

Adverse event: Other Induced Atrial or Ventricular Arrhythmias
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1930 at risk

Adverse event: Other Pulmonary Edema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 1930 at risk

Adverse event: Other Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1930 at risk