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 VVI;
Ventricular Lower Pacing Rate 60ppm;
Ventricular Pulse Width 0.4ms;
Ventricular Pulse Amplitude 3V;
Ventricle Impedance 510ohms;
Ventricle Sensing Rate 70bpm;
EGM prestorage OFF;
Charging frequency assumes maximum energy charge and includes therapy shocks and capacitor formation.
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Distribution Data
US Market Release
2003-10-06
CE Approval Date
2003-10-28
Registered USA Implants
43623
Estimated Active USA Implants
2773
Normal Battery Depletions
10367
US Market Release
2003-10-06
CE Approval Date
2003-10-28
Estimated WW Distribution
75208
Normal Battery Depletions
10674
Malfunctions (USA)
Therapy Function Not Compromised
58
Electrical Component
29
Possible Early Battery Depletion
25
Software/Firmware
2
Other
2
Therapy Function Compromised
15
Electrical Component
12
Electrical Interconnect
1
Possible Early Battery Depletion
1
Other
1
Malfunctions (WW)
Therapy Function Not Compromised
115
Battery
2
Electrical Component
70
Possible Early Battery Depletion
35
Software/Firmware
5
Other
3
Therapy Function Compromised
23
Electrical Component
20
Electrical Interconnect
1
Possible Early Battery Depletion
1
Other
1
EOL Indication
EOL device status is defined as three months following an ERI indication assuming the following post-ERI conditions: 100% VVI pacing at 60 ppm, 3 V, 0.4 ms; 500 Ohm pacing load; and six 30 J charges. EOL may be indicated before the end of three months if the device exceeds these conditions.
Elective Replacement (ERI)
Battery voltage less than or equal to 2.62v or charge time greater than 16 seconds.
