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 %;
EGM Prestorage ON ;
Upper Sensing Rate 130 ppm;
Atrial Percent Paced 100 %;
EGM Prestorage ON Time 1 ;
Atrial Fib Percent of Time 0 %
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Distribution Data
US Market Release
CE Approval Date
2017-03-02
Registered USA Implants
3
Estimated Active USA Implants
2
Normal Battery Depletions
US Market Release
CE Approval Date
2017-03-02
Estimated WW Distribution
323428
Normal Battery Depletions
1
Malfunctions (USA)
Therapy Function Not Compromised
Therapy Function Compromised
Malfunctions (WW)
Therapy Function Not Compromised
33
Battery
1
Electrical Component
26
Electrical Interconnect
1
Possible Early Battery Depletion
1
Software/Firmware
2
Other
2
Therapy Function Compromised
10
Battery
4
Electrical Component
5
Other
1
EOS Indication
From the point that the RRT is set, the pacemaker will operate for approximately six months for typical pacemaker configurations during the normal operating life.
Recommended Replacement (RRT)
Battery voltage less than or equal to 2.63V on 3 consecutive daily automatic measurements.
