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 ADDRL1 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
138605
Estimated Active USA Implants
64630
Normal Battery Depletions
2889
US Market Release
2006-07-17
CE Approval Date
2005-09-20
Estimated WW Distribution
319688
Normal Battery Depletions
3476
Malfunctions (USA)
Therapy Function Not Compromised
17
Electrical Component
13
Electrical Interconnect
1
Possible Early Battery Depletion
2
Software/Firmware
1
Therapy Function Compromised
8
Electrical Component
5
Electrical Interconnect
1
Other
2
Malfunctions (WW)
Therapy Function Not Compromised
42
Electrical Component
37
Electrical Interconnect
2
Possible Early Battery Depletion
2
Software/Firmware
1
Therapy Function Compromised
19
Electrical Component
16
Electrical Interconnect
1
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).
