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 %Hide this content
Distribution Data
US Market Release
CE Approval Date
2017-02-10
Registered USA Implants
Estimated Active USA Implants
Normal Battery Depletions
US Market Release
CE Approval Date
2017-02-10
Estimated WW Distribution
11861
Normal Battery Depletions
Malfunctions (USA)
Therapy Function Not Compromised
Therapy Function Compromised
Malfunctions (WW)
Therapy Function Not Compromised
2
Other
2
Therapy Function Compromised
1
Battery
1
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
