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;
Charging frequency assumes maximum energy charge and includes therapy shocks and capacitor formation.
Hide this content
Distribution Data
US Market Release
2008-09-15
CE Approval Date
Registered USA Implants
49639
Estimated Active USA Implants
5403
Normal Battery Depletions
10310
US Market Release
2008-09-15
CE Approval Date
Estimated WW Distribution
50530
Normal Battery Depletions
10318
Malfunctions (USA)
Therapy Function Not Compromised
115
Battery
14
Electrical Component
38
Possible Early Battery Depletion
50
Software/Firmware
9
Other
4
Therapy Function Compromised
37
Battery
21
Electrical Component
13
Possible Early Battery Depletion
1
Software/Firmware
1
Other
1
Malfunctions (WW)
Therapy Function Not Compromised
116
Battery
14
Electrical Component
39
Possible Early Battery Depletion
50
Software/Firmware
9
Other
4
Therapy Function Compromised
37
Battery
21
Electrical Component
13
Possible Early Battery Depletion
1
Software/Firmware
1
Other
1
EOS Indication
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.