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 formation.
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Distribution Data
US Market Release
2013-04-03
CE Approval Date
2013-12-17
Registered USA Implants
11810
Estimated Active USA Implants
5701
Normal Battery Depletions
498
US Market Release
2013-04-03
CE Approval Date
2013-12-17
Estimated WW Distribution
30682
Normal Battery Depletions
504
Malfunctions (USA)
Therapy Function Not Compromised
5
Battery
3
Electrical Component
2
Therapy Function Compromised
8
Battery
5
Device-Related Current Pathway
1
Electrical Component
1
Possible Early Battery Depletion
1
Malfunctions (WW)
Therapy Function Not Compromised
23
Battery
12
Electrical Component
11
Therapy Function Compromised
14
Battery
9
Device-Related Current Pathway
1
Electrical Component
3
Possible Early Battery Depletion
1
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 or equal to 2.73V on 3 consecutive daily automatic measurments.
