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;
Integrated bi-ventricular pacing RV+LV;
Left Ventricle Impedance 510ohms;
Left Ventricular Pulse Width 0.4ms;
Left Ventricular Pulse Amplitude 3V;
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
2011-03-25
CE Approval Date
Registered USA Implants
41864
Estimated Active USA Implants
4649
Normal Battery Depletions
10523
US Market Release
2011-03-25
CE Approval Date
Estimated WW Distribution
43042
Normal Battery Depletions
10546
Malfunctions (USA)
Therapy Function Not Compromised
75
Battery
8
Electrical Component
40
Possible Early Battery Depletion
25
Other
2
Therapy Function Compromised
19
Battery
11
Electrical Component
8
Malfunctions (WW)
Therapy Function Not Compromised
76
Battery
8
Electrical Component
41
Possible Early Battery Depletion
25
Other
2
Therapy Function Compromised
19
Battery
11
Electrical Component
8
EOL 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 2.63V on 3 consecutive daily automatic measurments.
