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
2011-03-25
CE Approval Date
Registered USA Implants
34746
Estimated Active USA Implants
4594
Normal Battery Depletions
4554
US Market Release
2011-03-25
CE Approval Date
Estimated WW Distribution
35499
Normal Battery Depletions
4556
Malfunctions (USA)
Therapy Function Not Compromised
40
Battery
8
Electrical Component
26
Electrical Interconnect
1
Possible Early Battery Depletion
4
Other
1
Therapy Function Compromised
37
Battery
30
Electrical Component
7
Malfunctions (WW)
Therapy Function Not Compromised
41
Battery
8
Electrical Component
26
Electrical Interconnect
1
Possible Early Battery Depletion
4
Other
2
Therapy Function Compromised
37
Battery
30
Electrical Component
7
EOL Indicator
The Prolonged Service Period (PSP) is the time between the RRT and EOS. The PSP is defined as 3 months assuming the following conditions: 100% DDD pacing at 60 min-1, 2.5 V atrial and RV pacing amplitude; 0.4 ms pulse width; 600 Ω pacing load; and 6 full-energy charges. The EOS may be indicated before the end of 3 months if the device exceeds these conditions.
Recommended Replacement (RRT)
Battery voltage less than or equal to 2.63V on 3 consecutive daily automatic measurements.
