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 VVI ;
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;
EGM Prestorage ON Time 1 ;
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Distribution Data
US Market Release
2015-03-19
CE Approval Date
2014-04-24
Registered USA Implants
28082
Estimated Active USA Implants
15729
Normal Battery Depletions
57
US Market Release
2015-03-19
CE Approval Date
2014-04-24
Estimated WW Distribution
85786
Normal Battery Depletions
58
Malfunctions (USA)
Therapy Function Not Compromised
8
Electrical Component
3
Electrical Interconnect
1
Possible Early Battery Depletion
2
Other
2
Therapy Function Compromised
1
Electrical Component
1
Malfunctions (WW)
Therapy Function Not Compromised
21
Electrical Component
14
Electrical Interconnect
2
Possible Early Battery Depletion
3
Other
2
Therapy Function Compromised
1
Electrical Component
1
EOS Indication
The Prolonged Service Period (PSP) is the time between the RRT and EOS. The PSP is defined as 6 months assuming the following conditions: 100% VVI pacing at 60 min–1, 2.5 V RV pacing amplitude; 0.4 ms pulse width; and 600 Ω pacing load. The EOS may be indicated before the end of 6 months if the device exceeds these conditions.
Recommended Replacement (RRT)
Battery voltage less than or equal to 2.83V on 3 consecutive daily automatic measurments.
