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 %;
Upper Sensing Rate 130 ppm;
Atrial Percent Paced 100 %;
Atrial Fib Percent of Time 0 %Hide this content
Distribution Data
US Market Release
2011-02-08
CE Approval Date
Registered USA Implants
69114
Estimated Active USA Implants
14329
Normal Battery Depletions
11871
US Market Release
2011-02-08
CE Approval Date
Estimated WW Distribution
69859
Normal Battery Depletions
11876
Malfunctions (USA)
Therapy Function Not Compromised
108
Battery
1
Electrical Component
40
Electrical Interconnect
1
Possible Early Battery Depletion
61
Software/Firmware
4
Other
1
Therapy Function Compromised
3
Electrical Component
3
Malfunctions (WW)
Therapy Function Not Compromised
113
Battery
2
Electrical Component
42
Electrical Interconnect
1
Possible Early Battery Depletion
61
Software/Firmware
6
Other
1
Therapy Function Compromised
3
Electrical Component
3
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 (VOO/65 with magnet).
