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
2009-06-02
Registered USA Implants
22
Estimated Active USA Implants
3
Normal Battery Depletions
4
US Market Release
CE Approval Date
2009-06-02
Estimated WW Distribution
444879
Normal Battery Depletions
34
Malfunctions (USA)
Therapy Function Not Compromised
Therapy Function Compromised
Malfunctions (WW)
Therapy Function Not Compromised
52
Battery
1
Electrical Component
34
Electrical Interconnect
1
Possible Early Battery Depletion
9
Software/Firmware
1
Other
6
Therapy Function Compromised
7
Electrical Component
5
Electrical Interconnect
1
Possible Early Battery Depletion
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 2.83V on 3 consecutive daily automatic measurments.
