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
2002-12-17
CE Approval Date
2002-08-21
Registered USA Implants
237
Estimated Active USA Implants
11
Normal Battery Depletions
25
US Market Release
2002-12-17
CE Approval Date
2002-08-21
Estimated WW Distribution
645
Normal Battery Depletions
26
Malfunctions (USA)
Therapy Function Not Compromised
0
Therapy Function Compromised
1
Battery
1
Malfunctions (WW)
Therapy Function Not Compromised
0
Therapy Function Compromised
1
Battery
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.
