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
2012-12-17
Registered USA Implants
15928
Estimated Active USA Implants
7513
Normal Battery Depletions
645
US Market Release
2013-04-03
CE Approval Date
2012-12-17
Estimated WW Distribution
37761
Normal Battery Depletions
649
Malfunctions (USA)
Therapy Function Not Compromised
9
Battery
7
Electrical Component
2
Therapy Function Compromised
9
Battery
6
Device-Related Current Pathway
1
Electrical Component
2
Malfunctions (WW)
Therapy Function Not Compromised
25
Battery
20
Electrical Component
5
Therapy Function Compromised
14
Battery
10
Device-Related Current Pathway
2
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 or equal to 2.73V on 3 consecutive daily automatic measurments.
