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 %;
These estimates are adjusted to reflect changes addressed by February 2010 Advisory "Low Battery Voltage Displayed at Device Interrogation".Hide this content
Distribution Data
US Market Release
2005-05-05
CE Approval Date
2004-08-13
Registered USA Implants
110024
Estimated Active USA Implants
7981
Normal Battery Depletions
17459
US Market Release
2005-05-05
CE Approval Date
2004-08-13
Estimated WW Distribution
142802
Normal Battery Depletions
18050
Malfunctions (USA)
Therapy Function Not Compromised
15102
Battery
14971
Electrical Component
59
Electrical Interconnect
2
Possible Early Battery Depletion
69
Other
1
Therapy Function Compromised
55
Battery
6
Electrical Component
38
Electrical Interconnect
4
Possible Early Battery Depletion
2
Other
5
Malfunctions (WW)
Therapy Function Not Compromised
17882
Battery
17669
Electrical Component
116
Electrical Interconnect
5
Possible Early Battery Depletion
88
Software/Firmware
1
Other
3
Therapy Function Compromised
77
Battery
10
Electrical Component
52
Electrical Interconnect
5
Possible Early Battery Depletion
5
Other
5
EOL 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.
Elective Replacement (ERI)
Telemetry indication. Rate and Mode change to 65 ppm and VVI (VOO/65 with magnet).
