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.
*The second longevity numbers provided apply to the N-series Adapta ADD01 product. The N-series products have increased longevity because of improved electronic circuitry. Click on "Other Articles" for more information on the N-series longevity.
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
2006-07-17
CE Approval Date
2005-09-20
Registered USA Implants
1
Estimated Active USA Implants
0
Normal Battery Depletions
US Market Release
2006-07-17
CE Approval Date
2005-09-20
Estimated WW Distribution
32243
Normal Battery Depletions
50
Malfunctions (USA)
Therapy Function Not Compromised
Therapy Function Compromised
Malfunctions (WW)
Therapy Function Not Compromised
1
Electrical Component
1
Therapy Function Compromised
1
Electrical Component
1
EOS Indication
The 3 month prolonged service period between RRT/ERI and EOS
assumes 100% pacing in VVI mode, rate of 65 ppm, RV Amplitude
of 3.5 V, RV Pulse Width of 0.4 ms, and pacing load of 500 OHMS;.
Reprogramming the pacing parameters may reduce the duration of the
prolonged service period.
Recommended Replacement (RRT)
Telemetry indication. Rate and mode change to 65 ppm and VVI respectively (VOO/65 with magnet).