Study: NCT02290028

Adverse event: Cardiac perforation associated with the RA lead
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2226 at risk

Adverse event: Cardiac perforation associated with the RV lead
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 2226 at risk

Adverse event: Cardiac perforation associated with the LV lead
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2226 at risk

Adverse event: Inability to place LV lead
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 2226 at risk

Adverse event: RA lead related lead dislodgement
Serious: yes
Organ System: Cardiac disorders
Frequency: 31 affected / 2226 at risk

Adverse event: RV lead related lead dislodgement
Serious: yes
Organ System: Cardiac disorders
Frequency: 22 affected / 2226 at risk

Adverse event: RV lead related elevated pacing threshold
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 2226 at risk

Adverse event: RV lead impedance out of range, high impedance
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 2226 at risk

Adverse event: RV lead related clinical failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 2226 at risk

Adverse event: RV lead related mechanical failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2226 at risk

Adverse event: RV lead undersensing or loss of sensing
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2226 at risk

Adverse event: Endocarditis associated with the RV lead
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2226 at risk

Adverse event: LV lead related lead dislodgement
Serious: yes
Organ System: Cardiac disorders
Frequency: 59 affected / 2226 at risk

Adverse event: LV lead related extracardiac stimulation
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 2226 at risk

Adverse event: LV lead related mechanical failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 2226 at risk

Adverse event: LV lead related high pacing threshold
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2226 at risk

Adverse event: LV lead related elevated pacing threshold
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2226 at risk

Adverse event: LV lead related clinical failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2226 at risk

Adverse event: LV lead related loss of capture
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2226 at risk

Adverse event: ICD device migration
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 2226 at risk

Adverse event: ICD device related inappropriate shock or ATP
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 2226 at risk

Adverse event: ICD device related electronic failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2226 at risk

Adverse event: Twiddler's syndrome
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 2226 at risk

Adverse event: Implant procedure related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 23 affected / 2226 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 2226 at risk

Adverse event: Pocket infection
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 2226 at risk

Adverse event: Cardiac perforation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 2226 at risk

Adverse event: Arrhythmia associated with implant procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 7 affected / 2226 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 17 affected / 2226 at risk

Adverse event: Loose set-screw
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 2226 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 16 affected / 2226 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 2226 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 2226 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 2226 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 2226 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 2226 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 2226 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 2226 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 2226 at risk

Adverse event: Wound healing disturbance
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 2226 at risk

Adverse event: Venous occlusion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 2226 at risk

Adverse event: Discomfort/pain
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 2226 at risk

Adverse event: Post surgical bleeding
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 2226 at risk

Adverse event: Post procedure anemia
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 2226 at risk

Adverse event: Allergy to contrast agent
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 2226 at risk

Adverse event: Elevated WBD and labs post procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 2226 at risk

Adverse event: Inflammation and swelling at surgical site
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 2226 at risk

Adverse event: RA lead elevated pacing threshold
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2226 at risk

Adverse event: LV lead electrical lead failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2226 at risk

Adverse event: LV lead impedance out of range, high
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2226 at risk

Adverse event: Inability to place LV lead
Serious: no
Organ System: Cardiac disorders
Frequency: 101 affected / 2226 at risk

Adverse event: RA lead related lead dislodgement
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 2226 at risk

Adverse event: RA lead related undersensing
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 2226 at risk

Adverse event: RV lead related clinical failure
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 2226 at risk

Adverse event: RV lead related extracardiac stimulation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2226 at risk

Adverse event: RV lead related high pacing threshold
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2226 at risk

Adverse event: RV lead related oversensing
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2226 at risk

Adverse event: LV lead related extracardiac stimulation
Serious: no
Organ System: Cardiac disorders
Frequency: 258 affected / 2226 at risk

Adverse event: LV lead related elevated pacing threshold
Serious: no
Organ System: Cardiac disorders
Frequency: 132 affected / 2226 at risk

Adverse event: LV lead related lead dislodgement
Serious: no
Organ System: Cardiac disorders
Frequency: 27 affected / 2226 at risk

Adverse event: LV lead related loss of capture
Serious: no
Organ System: Cardiac disorders
Frequency: 24 affected / 2226 at risk

Adverse event: LV lead impedance out of range, high impedance
Serious: no
Organ System: Cardiac disorders
Frequency: 19 affected / 2226 at risk

Adverse event: LV lead related high pacing threshold
Serious: no
Organ System: Cardiac disorders
Frequency: 38 affected / 2226 at risk

Adverse event: LV lead related clinical failure
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 2226 at risk

Adverse event: LV lead related oversensing
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 2226 at risk

Adverse event: LV lead related mechanical failure
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 2226 at risk

Adverse event: LV lead related electrical failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2226 at risk

Adverse event: LV lead related loss of sensing
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2226 at risk

Adverse event: ICD device migration
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2226 at risk

Adverse event: ICD device related inappropriate shock or ATP
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 2226 at risk

Adverse event: ICD device related housing defect
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2226 at risk

Adverse event: ICD device related high defibrillator (DFT) testing
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 2226 at risk

Adverse event: ICD device related pacemaker mediated tachycardia (PMT)
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 2226 at risk

Adverse event: Twiddler's syndrome
Serious: no
Organ System: General disorders
Frequency: 3 affected / 2226 at risk

Adverse event: Rachet syndrome
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2226 at risk

Adverse event: Implant procedure related infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 2226 at risk

Adverse event: Arrhythmia associated with implant procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 5 affected / 2226 at risk

Adverse event: Haematoma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 12 affected / 2226 at risk

Adverse event: Cardiac vein dissection
Serious: no
Organ System: Surgical and medical procedures
Frequency: 9 affected / 2226 at risk

Adverse event: Loose set-screw
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 2226 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 2226 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 2226 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 2226 at risk

Adverse event: Bleeding at surgical site
Serious: no
Organ System: Surgical and medical procedures
Frequency: 7 affected / 2226 at risk

Adverse event: Allergy to surgery prep
Serious: no
Organ System: Surgical and medical procedures
Frequency: 6 affected / 2226 at risk

Adverse event: Unsuccessful defibrillator threshold (DFT) testing
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 2226 at risk

Adverse event: Wound healing disturbance
Serious: no
Organ System: Surgical and medical procedures
Frequency: 5 affected / 2226 at risk

Adverse event: Venous occlusion
Serious: no
Organ System: Surgical and medical procedures
Frequency: 6 affected / 2226 at risk

Adverse event: Discomfort/pain at surgical site
Serious: no
Organ System: Surgical and medical procedures
Frequency: 14 affected / 2226 at risk

Adverse event: RA lead elevated pacing threshold
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 2226 at risk

Adverse event: RA lead related extracardiac stimulation
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 2226 at risk

Adverse event: RA lead related thrombosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2226 at risk

Adverse event: Pain in shoulder after system revision
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 2226 at risk

Adverse event: Hypotension after insertion procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 2226 at risk

Adverse event: Bleeding caused by surgical prep
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 2226 at risk

Adverse event: Fever after insertion procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 2226 at risk

Adverse event: Emesis after insertion procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 2226 at risk