Study: NCT01688843

Adverse event: Pulse Generator
Serious: yes
Organ System: Product Issues
Notes: Includes:

Oversensing - Defibrillation Rate response inappropriate Inappropriate AV delay Pacemaker-mediated tachycardia (PMT) Erosion Infection (\> 30 days post-implant) Migration
Frequency: 9 affected / 1041 at risk

Adverse event: Right Atrial (RA) Lead - INGEVITY Related
Serious: yes
Organ System: Product Issues
Notes: 564 patients were attempted/implanted with a INGEVITY RA lead, therefore that is the number at risk for an adverse event
Frequency: 10 affected / 564 at risk

Adverse event: RA Lead - Other (Non-INGEVITY Lead)
Serious: yes
Organ System: Product Issues
Notes: 858 patients were attempted/implanted with an OTHER (non-INGEVITY) RA lead, therefore that is the number at risk for an adverse event
Frequency: 12 affected / 858 at risk

Adverse event: Right Ventricular (RV) Lead - INGEVITY-related
Serious: yes
Organ System: Product Issues
Notes: Includes:

Unable to capture - RV - INGEVITY-related Elevated threshold - RV - INGEVITY-related Extracardiac stimulation - RV - INGEVITY-related Conductor coil fracture - RV - INGEVITY-related Dislodgment - RV - INGEVITY-related
Frequency: 15 affected / 1041 at risk

Adverse event: RV Lead - Other (Non-INGEVITY Lead)
Serious: yes
Organ System: Product Issues
Notes: Includes:

Other - RV Lead - Other
Frequency: 1 affected / 1041 at risk

Adverse event: Left-Ventricular (LV) Lead
Serious: yes
Organ System: Product Issues
Notes: Includes:

Elevated threshold - LV Extracardiac stimulation - LV Dislodgment - LV
Frequency: 2 affected / 1041 at risk

Adverse event: Procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 26 affected / 1041 at risk

Adverse event: Cardiovascular - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 101 affected / 1041 at risk

Adverse event: Cardiovascular - Non-Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 241 affected / 1041 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 49 affected / 1041 at risk

Adverse event: Unclassified
Serious: yes
Organ System: Investigations
Frequency: 8 affected / 1041 at risk

Adverse event: Non-cardiovascular
Serious: yes
Organ System: General disorders
Frequency: 357 affected / 1041 at risk

Adverse event: Pulse Generator
Serious: no
Organ System: Product Issues
Frequency: 32 affected / 1041 at risk

Adverse event: RA Lead - INGEVITY-related
Serious: no
Organ System: Product Issues
Notes: 564 patients were attempted/implanted with an INGEVITY RA lead, therefore that is the number at risk for an adverse event
Frequency: 16 affected / 564 at risk

Adverse event: RA Lead - Other
Serious: no
Organ System: Product Issues
Notes: 858 patients were attempted/implanted with an OTHER (non-INGEVITY) RA lead, therefore that is the number at risk for an adverse event
Frequency: 4 affected / 858 at risk

Adverse event: RV Lead - INGEVITY-related
Serious: no
Organ System: Product Issues
Frequency: 11 affected / 1041 at risk

Adverse event: LV Lead
Serious: no
Organ System: Product Issues
Notes: 47 patients were attempted/implanted with any LV lead, therefore that is the number at risk for an adverse event
Frequency: 6 affected / 47 at risk

Adverse event: Procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 58 affected / 1041 at risk

Adverse event: Cardiovascular - HF
Serious: no
Organ System: Cardiac disorders
Frequency: 61 affected / 1041 at risk

Adverse event: Cardiovascular - Non-HF
Serious: no
Organ System: Cardiac disorders
Frequency: 412 affected / 1041 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 89 affected / 1041 at risk

Adverse event: Unclassified
Serious: no
Organ System: General disorders
Frequency: 9 affected / 1041 at risk