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 3V; Ventricular Pulse Amplitude 3V; Atrial Impedance 510ohms; Ventricle Impedance 510ohms; Atrial Sensing Rate 70bpm; Ventricle Sensing Rate 70bpm; EGM prestorage OFF; Optivol ON; 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
CE Approval Date
2014-03-31
Registered USA Implants
1
Estimated Active USA Implants
1
Normal Battery Depletions
US Market Release
CE Approval Date
2014-03-31
Estimated WW Distribution
74473
Normal Battery Depletions
21
Malfunctions (USA)
Therapy Function Not Compromised
Therapy Function Compromised
Malfunctions (WW)
Therapy Function Not Compromised
53
Battery
27
Electrical Component
23
Electrical Interconnect
1
Other
2
Therapy Function Compromised
12
Battery
9
Device-Related Current Pathway
1
Electrical Component
2
EOS Indication
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 2.73V on 3 consecutive daily automatic measurements.
