Including Normal Battery Depletion – This curve includes devices that have reached at least 80% of expected longevity. This curve is most representative of clinical performance and how long the device will last.
Excluding Normal Battery Depletion – This is the malfunction free survival curve.
Longevity estimates based on the following device usage. Pacing Mode DDD; Atrial Lower Pacing Rate 60ppm; Ventricular Lower Pacing Rate 60ppm; Atrial Pulse Width 0.4ms; Ventricular Pulse Width 0.4ms; Atrial Pulse Amplitude 1.5V; Ventricular Pulse Amplitude 2V; Atrial Impedance 500ohms; Ventricle Impedance 500ohms; Atrial Sensing Rate 70bpm; Ventricle Sensing Rate 70bpm;Atrial Fib percentage of time 0%; Charging frequency assumes maximum energy charge and includes therapy shocks and capacitor formationHide this content
Distribution Data
US Market Release
2020-04-23
CE Approval Date
2019-12-18
Registered USA Implants
4064
Estimated Active USA Implants
3710
Normal Battery Depletions
30
US Market Release
2020-04-23
CE Approval Date
2019-12-18
Estimated WW Distribution
15965
Normal Battery Depletions
30
Malfunctions (USA)
Therapy Function Not Compromised
1
Electrical Component
1
Therapy Function Compromised
2
Electrical Component
1
Electrical Interconnect
1
Malfunctions (WW)
Therapy Function Not Compromised
4
Battery
1
Electrical Component
1
Software/Firmware
2
Therapy Function Compromised
2
Electrical Component
1
Electrical Interconnect
1
EOS Indicator
From the point that the RRT is set, the pacemaker will operate for approximately three months for typical pacemaker configurations during the normal operating life.
Recommended Replacement (RRT)
Battery voltage less than or equal to 2.8 V on 3 consecutive daily automatic measurements.