Study: NCT00810264

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2499 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2499 at risk

Adverse event: Hypotensive arrest / hemodynamic collapse
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2499 at risk

Adverse event: ICD lead T-wave oversensing
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2499 at risk

Adverse event: ICD lead cardiac perforation with or without tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2499 at risk

Adverse event: ICD lead dislodgement
Serious: yes
Organ System: Cardiac disorders
Frequency: 34 affected / 2499 at risk

Adverse event: ICD lead high pacing threshold, intermittent capture, no lead capture
Serious: yes
Organ System: Cardiac disorders
Frequency: 14 affected / 2499 at risk

Adverse event: ICD lead impedance out of range, high impedance, potential conductor fracture
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 2499 at risk

Adverse event: ICD lead impedance out of range, low Impedance, potential insulation break
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 2499 at risk

Adverse event: ICD lead inability to defibrillate or pace
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2499 at risk

Adverse event: ICD lead oversensing or lead noise
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 2499 at risk

Adverse event: ICD lead undersensing or loss of sensing
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2499 at risk

Adverse event: ICD lead, Riata lead externalized
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2499 at risk

Adverse event: ICD lead, unknown, inadequate source documentation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2499 at risk

Adverse event: Inappropriate shocks
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2499 at risk

Adverse event: LV lead abnormal pacing impedance, high impedance
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 2499 at risk

Adverse event: LV lead cardiac perforation with or without tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2499 at risk

Adverse event: LV lead conductor fracture
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 2499 at risk

Adverse event: LV lead dislodgement
Serious: yes
Organ System: Cardiac disorders
Frequency: 61 affected / 2499 at risk

Adverse event: LV lead excess slack
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2499 at risk

Adverse event: LV lead high pacing threshold, intermittent capture, no lead capture
Serious: yes
Organ System: Cardiac disorders
Frequency: 14 affected / 2499 at risk

Adverse event: LV lead related diaphgramatic / pectoral stimulation
Serious: yes
Organ System: Cardiac disorders
Frequency: 14 affected / 2499 at risk

Adverse event: Non-functioning RA lead
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2499 at risk

Adverse event: Pocket pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2499 at risk

Adverse event: RA lead dislodgement
Serious: yes
Organ System: Cardiac disorders
Frequency: 29 affected / 2499 at risk

Adverse event: RA lead high pacing threshold, intermittent capture, no lead capture
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 2499 at risk

Adverse event: RA lead impedance out of range, high impedance, potential conductor fracture
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 2499 at risk

Adverse event: RA lead impedance out of range, low impedance, potential insulation break
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2499 at risk

Adverse event: RA lead oversensing or lead noise
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2499 at risk

Adverse event: RA lead undersensing or loss of sensing
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2499 at risk

Adverse event: RV pacing lead dislodgement
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2499 at risk

Adverse event: RV pacing lead impedance out of range, high impedance, potential conductor fracture
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2499 at risk

Adverse event: RV pacing lead noise
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2499 at risk

Adverse event: Suspected generator failure requiring opening of pulse generator pocket
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2499 at risk

Adverse event: Twiddler's syndrome
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 2499 at risk

Adverse event: Implant procedure related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 19 affected / 2499 at risk

Adverse event: Pocket infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2499 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 15 affected / 2499 at risk

Adverse event: Skin erosion
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 2499 at risk

Adverse event: Trauma related dehiscence
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 2499 at risk

Adverse event: Cardiac perforation with or without tamponade
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 2499 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 15 affected / 2499 at risk

Adverse event: High defibrillation thresholds due to inappropriate lead placement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 2499 at risk

Adverse event: Implant procedure related damage to the lead
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 2499 at risk

Adverse event: LV lead dislodgement during RV lead extraction
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 2499 at risk

Adverse event: Device fastener issue
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 2499 at risk

Adverse event: Non-healing pocket dehiscence requiring intervention
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 8 affected / 2499 at risk

Adverse event: Open heart surgery causing LV lead dislodgement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 2499 at risk

Adverse event: Persistent arm of unknown cause
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 2499 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 2499 at risk

Adverse event: Pocket pain
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 2499 at risk

Adverse event: RA lead dislodgement during LV lead placement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 2499 at risk

Adverse event: SVC perforation during laser lead extraction
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 2499 at risk

Adverse event: Subclavian vein occlusion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 2499 at risk

Adverse event: Arrhythmias
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 2499 at risk

Adverse event: Cardiac vein dissection
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 2499 at risk

Adverse event: Diaphragmatic stimulation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 2499 at risk

Adverse event: Haematoma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 22 affected / 2499 at risk

Adverse event: ICD lead high pacing threshold, intermittent capture, no lead capture
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 2499 at risk

Adverse event: ICD lead oversensing
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 2499 at risk

Adverse event: ICD lead oversensing or lead noise
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 2499 at risk

Adverse event: Incompletely healed incision
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 2499 at risk

Adverse event: LV lead abnormal pacing impedance, high impedance
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 2499 at risk

Adverse event: LV lead dislodgement
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 2499 at risk

Adverse event: High pacing threshold
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2499 at risk

Adverse event: LV lead high pacing threshold, intermittent capture, no lead capture
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 2499 at risk

Adverse event: LV lead related diaphgramatic / pectoral stimulation
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 2499 at risk

Adverse event: Left subclavian vein thrombosis
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 2499 at risk

Adverse event: Non-healing pocket dehiscence requiring intervention
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 2499 at risk

Adverse event: RA lead dislodgement
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2499 at risk

Adverse event: RA lead high pacing threshold, intermittent capture, no lead capture
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 2499 at risk

Adverse event: RA lead impedance out of range, high impedance, potential conductor fracture
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2499 at risk

Adverse event: RA lead impedance out of range, low impedance, potential insulation break
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2499 at risk

Adverse event: RA lead noise
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2499 at risk

Adverse event: RA lead oversensing or lead noise
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2499 at risk

Adverse event: Twiddler's syndrome
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2499 at risk