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 DDD ;
Atrial Pulse Width 0.4 ms;
Right Ventricle Pulse Width 0.4 ms;
Lower Pace Rate 60 bpm;
Right Ventricle Percent Paced 100 %;
Upper Sensing Rate 130 ppm;
Atrial Percent Paced 100 %;
Left Ventricle Pulse Width 0.4 ms;
Left Ventricle Pulse Amplitude same as A, RV;
Left Ventricle Percent Paced 100 %;
Left Ventricle Lead Impedance same as A, RV;
EGM Prestorage ON ;
EGM Prestorage ON Time 1 ;
Atrial Fib Percent of Time 0 %
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Distribution Data
US Market Release
2017-05-06
CE Approval Date
Registered USA Implants
8547
Estimated Active USA Implants
6929
Normal Battery Depletions
53
US Market Release
2017-05-06
CE Approval Date
Estimated WW Distribution
9105
Normal Battery Depletions
53
Malfunctions (USA)
Therapy Function Not Compromised
3
Electrical Component
3
Therapy Function Compromised
0
Malfunctions (WW)
Therapy Function Not Compromised
3
Electrical Component
3
Therapy Function Compromised
0
EOL Indicator
6 months after RRT
Recommended Replacement (RRT)
180 days after 3 consecutive daily automatic measurements of battery voltage less than or equal to 2.63 V or immediately after 3 consecutive daily automatic measurements of less than or equal to 2.60 V, whichever comes first