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.
Hide this content
EOS Indication
EOS device status is defined as 3 months following an RRT indication assuming the following PSP conditions: 100% DDD pacing at 60 min-1, 2.5 V, 0.4 ms;
500 Ohm pacing load; and 6 full-energy charges. EOS may be indicated before the end of 3 months if the device exceeds these conditions.
Distribution Data
US Market Release
CE Approval Date
2006-03-07
Registered USA Implants
Estimated Active USA Implants
Normal Battery Depletions
US Market Release
CE Approval Date
2006-03-07
Estimated WW Distribution
Normal Battery Depletions
Malfunctions (USA)
Therapy Function Not Compromised
Therapy Function Compromised
Malfunctions (WW)
Therapy Function Not Compromised
Therapy Function Compromised
Recommended Replacement (RRT)
Battery voltage less than or equal to 2.62V on 3 consecutive daily automatic measurments.
