Study: NCT01507987

Adverse event: Abnormal high voltage lead impredance
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 982 at risk

Adverse event: Device electrical impedance issue
Serious: yes
Organ System: Product Issues
Frequency: 8 affected / 982 at risk

Adverse event: Decline in R Wave Sensing
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 982 at risk

Adverse event: Lead dislodgement or migration
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 982 at risk

Adverse event: lead fracture
Serious: yes
Organ System: Product Issues
Frequency: 4 affected / 982 at risk

Adverse event: lead insulation damage
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 982 at risk

Adverse event: lead noise
Serious: yes
Organ System: Product Issues
Frequency: 4 affected / 982 at risk

Adverse event: Oversensing
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 982 at risk

Adverse event: Abnormal High Voltage Lead Impedance
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 982 at risk

Adverse event: Device electrical impedance issue
Serious: no
Organ System: Product Issues
Frequency: 5 affected / 982 at risk

Adverse event: Decrease R Wave
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 982 at risk

Adverse event: Elevated pacing thresholds
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 982 at risk

Adverse event: Lead Noise
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 982 at risk

Adverse event: Oversensing
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 982 at risk

Adverse event: Therapy for Non-Ventricular Rhythm
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 982 at risk

Adverse event: Abnormal high voltage lead impredance
Serious: yes
Organ System: Product Issues
Frequency: 5 affected / 670 at risk

Adverse event: Device electrical impedance issue
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 670 at risk

Adverse event: Elevated pacing thresholds
Serious: yes
Organ System: Product Issues
Frequency: 4 affected / 670 at risk

Adverse event: Externalized Conductor
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 670 at risk

Adverse event: lead fracture
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 670 at risk

Adverse event: lead insulation damage
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 670 at risk

Adverse event: lead noise
Serious: yes
Organ System: Product Issues
Frequency: 8 affected / 670 at risk

Adverse event: Oversensing
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 670 at risk

Adverse event: shock due to AF with RVR
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 670 at risk

Adverse event: Undersensing
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 670 at risk

Adverse event: Abnormal High Voltage Lead Impedance
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 670 at risk

Adverse event: Device electrical impedance issue
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 670 at risk

Adverse event: Elevated pacing thresholds
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 670 at risk

Adverse event: Lead Insulation Damage
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 670 at risk

Adverse event: Lead Noise
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 670 at risk

Adverse event: Undersensing
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 670 at risk

Adverse event: Oversensing
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 670 at risk

Adverse event: Therapy for Non-Ventricular Rhythm
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 670 at risk

Adverse event: Undersensing
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 670 at risk

Adverse event: Abnormal high voltage lead impredance
Serious: yes
Organ System: Product Issues
Frequency: 5 affected / 458 at risk

Adverse event: Elevated pacing thresholds
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 458 at risk

Adverse event: lead insulation damage
Serious: yes
Organ System: Product Issues
Frequency: 4 affected / 458 at risk

Adverse event: lead noise
Serious: yes
Organ System: Product Issues
Frequency: 8 affected / 458 at risk

Adverse event: Oversensing
Serious: yes
Organ System: Product Issues
Frequency: 4 affected / 458 at risk

Adverse event: Elevated pacing thresholds
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 458 at risk

Adverse event: Lead Noise
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 458 at risk

Adverse event: Other Visual Lead Anomalies
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 458 at risk

Adverse event: Oversensing
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 458 at risk

Adverse event: Oversensing Resulting in Therapy
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 458 at risk

Adverse event: Therapy for Non-Ventricular Rhythm
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 458 at risk

Adverse event: Elevated pacing thresholds
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 737 at risk

Adverse event: Lead dislodgement or migration
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 737 at risk

Adverse event: lead insulation damage
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 737 at risk

Adverse event: phrenic nerve/diaphragmatic stimulation
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 737 at risk

Adverse event: Device electrical impedance issue
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 737 at risk

Adverse event: Elevated pacing thresholds
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 737 at risk

Adverse event: Device capturing issue
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 737 at risk

Adverse event: Pectoral Stimulation
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 737 at risk

Adverse event: Phrenic Nerve/Diaphragmatic Stimulation
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 737 at risk