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
2016-12-05
CE Approval Date
Registered USA Implants
82866
Estimated Active USA Implants
67452
Normal Battery Depletions
1395
US Market Release
2016-12-05
CE Approval Date
Estimated WW Distribution
116128
Normal Battery Depletions
1395
Malfunctions (USA)
Therapy Function Not Compromised
21
Battery
2
Electrical Component
13
Electrical Interconnect
1
Possible Early Battery Depletion
1
Software/Firmware
1
Other
3
Therapy Function Compromised
11
Device-Related Current Pathway
5
Electrical Component
6
Malfunctions (WW)
Therapy Function Not Compromised
22
Battery
2
Electrical Component
14
Electrical Interconnect
1
Possible Early Battery Depletion
1
Software/Firmware
1
Other
3
Therapy Function Compromised
11
Device-Related Current Pathway
5
Electrical Component
6
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.
