Study: NCT02071173

Adverse event: Cardiovascular - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 620 affected / 2200 at risk

Adverse event: Cardiovascular - Non-Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 829 affected / 2200 at risk

Adverse event: Non-Cardiovascular
Serious: yes
Organ System: General disorders
Frequency: 1043 affected / 2200 at risk

Adverse event: Pulse Generator
Serious: yes
Organ System: Product Issues
Frequency: 74 affected / 2200 at risk

Adverse event: RA Lead
Serious: yes
Organ System: Product Issues
Frequency: 28 affected / 2007 at risk

Adverse event: RV Lead - Related to RELIANCE 4-FRONT
Serious: yes
Organ System: Product Issues
Frequency: 45 affected / 2090 at risk

Adverse event: RV Lead - Unrelated to / Not caused by RELIANCE 4-FRONT
Serious: yes
Organ System: Product Issues
Frequency: 6 affected / 2199 at risk

Adverse event: LV Lead - Related to ACUITY X4
Serious: yes
Organ System: Product Issues
Frequency: 24 affected / 2162 at risk

Adverse event: LV Lead - Unrelated to / Not caused by ACUITY X4
Serious: yes
Organ System: Product Issues
Frequency: 9 affected / 2182 at risk

Adverse event: RV & LV Lead - Related to both RELIANCE 4-FRONT and ACUITY X4
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 2109 at risk

Adverse event: Lead - Other
Serious: yes
Organ System: Product Issues
Frequency: 16 affected / 2019 at risk

Adverse event: Procedure-related
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 107 affected / 2200 at risk

Adverse event: Unclassified
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 2200 at risk

Adverse event: Cardiovascular - Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 543 affected / 2200 at risk

Adverse event: Cardiovascular - Non-Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1105 affected / 2200 at risk

Adverse event: Non-Cardiovascular
Serious: no
Organ System: General disorders
Frequency: 1341 affected / 2200 at risk

Adverse event: Pulse Generator
Serious: no
Organ System: Product Issues
Frequency: 262 affected / 2200 at risk

Adverse event: RA Lead
Serious: no
Organ System: Product Issues
Frequency: 43 affected / 2007 at risk

Adverse event: RV Lead - Related to RELIANCE 4-FRONT
Serious: no
Organ System: Product Issues
Frequency: 41 affected / 2090 at risk

Adverse event: RV Lead - Unrelated to / Not caused by RELIANCE 4-FRONT
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 2199 at risk

Adverse event: LV Lead - Related to ACUITY X4
Serious: no
Organ System: Product Issues
Frequency: 271 affected / 2162 at risk

Adverse event: LV Lead - Unrelated to / Not caused by ACUITY X4
Serious: no
Organ System: Product Issues
Frequency: 9 affected / 2182 at risk

Adverse event: RV & LV Lead - Related to both RELIANCE 4-FRONT and ACUITY X4
Serious: no
Organ System: Product Issues
Frequency: 8 affected / 2109 at risk

Adverse event: Lead - Other
Serious: no
Organ System: Product Issues
Frequency: 6 affected / 2109 at risk

Adverse event: Procedure-related
Serious: no
Organ System: Surgical and medical procedures
Frequency: 297 affected / 2200 at risk

Adverse event: Unclassified
Serious: no
Organ System: Investigations
Frequency: 8 affected / 2200 at risk