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.
Pace/Sense Mode VVI ;
Right Ventricle Pulse Width 0.4 ms;
Lower Pace Rate 60 bpm;
Right Ventricle Percent Paced 100 %;
Upper Sensing Rate 130 ppm;
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Distribution Data
US Market Release
2017-08-03
CE Approval Date
2017-06-16
Registered USA Implants
Estimated Active USA Implants
Normal Battery Depletions
US Market Release
2017-08-03
CE Approval Date
2017-06-16
Estimated WW Distribution
72252
Normal Battery Depletions
1
Malfunctions (USA)
Therapy Function Not Compromised
Therapy Function Compromised
Malfunctions (WW)
Therapy Function Not Compromised
1
Electrical Component
1
Therapy Function Compromised
1
Electrical Component
1
EOL Indicator
180 days from RRT
Recommended Replacement (RRT)
Battery voltage less than or equal to 2.5 V, or battery voltage less than or equal to 2.59 V and battery impedance at 3000 ohms
