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 %;
Left Ventricle Pulse Width 0.4 ms;
Left Ventricle Pulse Amplitude same as A, RV;
Left Ventricle Percent Paced 100 %;
Left Ventricle Lead Impedance same as A, RV;
Atrial Fib Percent of Time 0 %;
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Distribution Data
US Market Release
2003-02-25
CE Approval Date
2001-02-07
Registered USA Implants
39276
Estimated Active USA Implants
1876
Normal Battery Depletions
5246
US Market Release
2003-02-25
CE Approval Date
2001-02-07
Estimated WW Distribution
97291
Normal Battery Depletions
5636
Malfunctions (USA)
Therapy Function Not Compromised
67
Battery
55
Electrical Component
2
Electrical Interconnect
3
Possible Early Battery Depletion
2
Other
5
Therapy Function Compromised
49
Battery
37
Electrical Interconnect
12
Malfunctions (WW)
Therapy Function Not Compromised
136
Battery
115
Electrical Component
8
Electrical Interconnect
6
Possible Early Battery Depletion
2
Other
5
Therapy Function Compromised
83
Battery
51
Electrical Component
3
Electrical Interconnect
29
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).
