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;
Optivol ON;
Charging frequency assumes maximum energy charge and includes therapy shocks and capacitor formation.
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Distribution Data
US Market Release
2018-03-01
CE Approval Date
2017-11-10
Registered USA Implants
274
Estimated Active USA Implants
242
Normal Battery Depletions
US Market Release
2018-03-01
CE Approval Date
2017-11-10
Estimated WW Distribution
11141
Normal Battery Depletions
Malfunctions (USA)
Therapy Function Not Compromised
Therapy Function Compromised
Malfunctions (WW)
Therapy Function Not Compromised
1
Electrical Component
1
Therapy Function Compromised
1
Device-Related Current Pathway
1
EOS Indicator
From the point that the RRT is set, the pacemaker will operate for approximately three months for typical pacemaker configurations during the normal operating life.
Recommended Replacement (RRT)
Battery voltage less than 2.73V on 3 consecutive daily automatic measurements.