Study: NCT00836589

Adverse event: ICD lead dislodgement (occuring <= 180 days post-implant procedure)
Serious: yes
Organ System: Cardiac disorders
Frequency: 24 affected / 1997 at risk

Adverse event: ICD lead high pacing threshold, intermittent capture, no lead capture
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 1997 at risk

Adverse event: ICD lead related cardiac perforation with or without tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1997 at risk

Adverse event: ICD lead impedance out of range, low impedance, potential insulation break
Serious: yes
Organ System: Cardiac disorders
Frequency: 25 affected / 1997 at risk

Adverse event: ICD lead impedance out of range, high impedance, potential conductor fracture
Serious: yes
Organ System: Cardiac disorders
Frequency: 18 affected / 1997 at risk

Adverse event: Other ICD lead related: lead noise or oversensing
Serious: yes
Organ System: Cardiac disorders
Frequency: 17 affected / 1997 at risk

Adverse event: ICD lead dislodgement (occuring > 180 days post-implant procedure)
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 1997 at risk

Adverse event: ICD lead undersensing or loss of sensing
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1997 at risk

Adverse event: ICD lead inability to defibrillate or pace
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1997 at risk

Adverse event: Other ICD lead related: no slack in the lead due to probable dislodgement
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1997 at risk

Adverse event: Other ICD lead related: noise consistent with probable fracture
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1997 at risk

Adverse event: Other ICD lead related: tension pneumothorax
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1997 at risk

Adverse event: Pocket pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1997 at risk

Adverse event: Unable to interrogate device
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1997 at risk

Adverse event: Suspected generator failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1997 at risk

Adverse event: Premature battery depletion, warranting device replacement
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1997 at risk

Adverse event: RA lead dislodgement
Serious: yes
Organ System: Cardiac disorders
Frequency: 18 affected / 1997 at risk

Adverse event: RA lead impedance out of range, high impedance, potential conductor fracture
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1997 at risk

Adverse event: RA lead undersensing or loss of sensing
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1997 at risk

Adverse event: RA lead oversensing or noise
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1997 at risk

Adverse event: RA lead high pacing threshold, intermittent capture, no lead capture
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1997 at risk

Adverse event: RA lead loose set screw
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1997 at risk

Adverse event: Infection not due to secondary infection
Serious: yes
Organ System: Infections and infestations
Frequency: 27 affected / 1997 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 7 affected / 1997 at risk

Adverse event: Device fastener issue
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 1997 at risk

Adverse event: Non-healing pocket dehiscence requiring intervention
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 1997 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1997 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1997 at risk

Adverse event: Impending erosion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1997 at risk

Adverse event: Pain at insertion site
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1997 at risk

Adverse event: Pocket erosion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1997 at risk

Adverse event: Pulmonary embolism (unrelated to ICD lead)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1997 at risk

Adverse event: Shock coils reversed in header
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1997 at risk

Adverse event: Infection due to secondary infection
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 1997 at risk

Adverse event: Twiddler's syndrome
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 1997 at risk

Adverse event: Skin erosion
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1997 at risk

Adverse event: Pulseless electrical activity (PEA) arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1997 at risk

Adverse event: LV lead dislodgement
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1997 at risk

Adverse event: Thrombus attached to ICD lead (unrelated to ICD lead)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1997 at risk

Adverse event: ICD lead high pacing threshold, intermittent capture, no lead capture
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1997 at risk

Adverse event: ICD lead impedance out of range, high impedance, potential conductor fracture
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1997 at risk

Adverse event: RA lead dislodgement
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 1997 at risk

Adverse event: RA lead impedance out of range, high impedance, potential conductor fracture
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1997 at risk

Adverse event: RA lead oversensing or noise
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1997 at risk

Adverse event: Infection not due to secondary infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1997 at risk

Adverse event: Haematoma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 12 affected / 1997 at risk