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
2013-01-15
CE Approval Date
Registered USA Implants
344413
Estimated Active USA Implants
217681
Normal Battery Depletions
6817
US Market Release
2013-01-15
CE Approval Date
Estimated WW Distribution
351077
Normal Battery Depletions
6821
Malfunctions (USA)
Therapy Function Not Compromised
75
Battery
1
Electrical Component
38
Electrical Interconnect
4
Possible Early Battery Depletion
23
Software/Firmware
6
Other
3
Therapy Function Compromised
5
Electrical Component
5
Malfunctions (WW)
Therapy Function Not Compromised
78
Battery
1
Electrical Component
41
Electrical Interconnect
4
Possible Early Battery Depletion
23
Software/Firmware
6
Other
3
Therapy Function Compromised
5
Electrical Component
5
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 2.83V on 3 consecutive daily automatic measurments.
