Study: NCT00940888

Adverse event: RV Lead or DF4 Connector Related Complication
Serious: no
Organ System: General disorders
Notes: RV lead or DF4 connector related complications (an adverse event caused by or associated with the study device, system component(s), and or procedure that requires invasive intervention)
Frequency: 50 affected / 1701 at risk

Adverse event: System and/or Procedure Related Complication
Serious: no
Organ System: General disorders
Notes: Various complications (an adverse event caused by or associated with the study device, system component(s), and or procedure that requires invasive intervention) reported that did not meet the \<1% report threshold.
Frequency: 44 affected / 1701 at risk

Adverse event: Infection Complication
Serious: no
Organ System: Infections and infestations
Notes: Infection complications (an adverse event caused by or associated with the study device, system component(s), and or procedure that requires invasive intervention) reported.
Frequency: 36 affected / 1701 at risk

Adverse event: LV Lead Dislodgment or Migration Complication
Serious: no
Organ System: General disorders
Notes: LV Lead dislodgement and migration complication (an adverse event caused by or associated with the study device, system component(s), and or procedure that requires invasive intervention).
Frequency: 21 affected / 1701 at risk

Adverse event: RA Lead Dislodgement or Migration Complication
Serious: no
Organ System: General disorders
Notes: RA lead dislodgement complication (an adverse event caused by or associated with the study device, system component(s), and or procedure that requires invasive intervention).
Frequency: 21 affected / 1701 at risk

Adverse event: Lead Dislodgement or Migration <30 days after Implant Complication
Serious: no
Organ System: Surgical and medical procedures
Notes: All were resolved with lead repositioning or replacement.
Frequency: 21 affected / 1701 at risk

Adverse event: System and/or Procedure Related Observation
Serious: no
Organ System: General disorders
Notes: Observations (an adverse event caused by or associated with the study device, system component(s), and or procedure that does not require invasive intervention) that did not meet the \<1% reporting threshold.
Frequency: 38 affected / 1701 at risk

Adverse event: RV Lead or DF4 Connector Related Observation
Serious: no
Organ System: General disorders
Notes: Summary of RV Lead or DF4 Connector Related Observations (an adverse event caused by or associated with the study device, system component(s), and or procedure that does not require invasive intervention).
Frequency: 45 affected / 1701 at risk

Adverse event: Elevated LV Pacing Thresholds Observation
Serious: no
Organ System: General disorders
Notes: Elevated LV pacing threshold observations ((an adverse event caused by or associated with the study device, system component(s), and or procedure that does not require invasive intervention).
Frequency: 21 affected / 1701 at risk

Adverse event: Inappropriate Shock(s) Observation
Serious: no
Organ System: General disorders
Notes: Therapy delivered for non-ventricular arrhythmias falling within the VT zones programmed in the device reported observations.
Frequency: 33 affected / 1701 at risk

Adverse event: LV Phrenic Nerve/ Diaphragmatic Stimulation Observation
Serious: no
Organ System: General disorders
Notes: LV Phrenic nerve/ diaphragmatic stimulation observation(an adverse event caused by or associated with the study device, system component(s), and or procedure that does not require invasive intervention).
Frequency: 51 affected / 1701 at risk

Adverse event: RA Oversensing Observation
Serious: no
Organ System: General disorders
Notes: RA over sensing observations (an adverse event caused by or associated with the study device, system component(s), and or procedure that does not require invasive intervention).
Frequency: 40 affected / 1701 at risk

Adverse event: Bleeding/ Hematoma Observation
Serious: no
Organ System: Surgical and medical procedures
Notes: Oozing/bleeding at site of incision following implant/system revision of implanted device system observation.
Frequency: 38 affected / 1701 at risk