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 ADDRS1 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
49315
Estimated Active USA Implants
9525
Normal Battery Depletions
6727
US Market Release
2006-07-17
CE Approval Date
2005-09-20
Estimated WW Distribution
86053
Normal Battery Depletions
6767
Malfunctions (USA)
Therapy Function Not Compromised
9
Electrical Component
5
Possible Early Battery Depletion
3
Other
1
Therapy Function Compromised
6
Electrical Component
4
Other
2
Malfunctions (WW)
Therapy Function Not Compromised
14
Electrical Component
9
Possible Early Battery Depletion
3
Software/Firmware
1
Other
1
Therapy Function Compromised
10
Electrical Component
8
Other
2
EOS Indication
From the point that the ERI is set, the pacemaker will operate at ERI conditions for approximately three months for typical pacemaker configurations during the normal operating life.
Recommended Replacement (RRT)
Telemetry indication. Rate and mode change to 65 ppm and VVI respectively (VOO/65 with magnet).
