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.
Pacing Mode DDD;
Atrial Lower Pacing Rate 60ppm;
Ventricular Lower Pacing Rate 60ppm;
Atrial Pulse Width 0.4ms;
Ventricular Pulse Width 0.4ms;
Atrial Pulse Amplitude 3V;
Ventricular Pulse Amplitude 3V;
Atrial Impedance 510ohms;
Ventricle Impedance 510ohms;
Atrial Sensing Rate 70bpm;
Ventricle Sensing Rate 70bpm;
EGM prestorage OFF;
Optivol ON;
Atrial Fib percentage of time 0%;
Charging frequency assumes maximum energy charge and includes therapy shocks and capacitor formation.
Hide this content
Distribution Data
US Market Release
2013-04-03
CE Approval Date
Registered USA Implants
82209
Estimated Active USA Implants
39936
Normal Battery Depletions
2737
US Market Release
2013-04-03
CE Approval Date
Estimated WW Distribution
84855
Normal Battery Depletions
2737
Malfunctions (USA)
Therapy Function Not Compromised
47
Battery
28
Device-Related Current Pathway
1
Electrical Component
15
Software/Firmware
1
Other
2
Therapy Function Compromised
35
Battery
30
Device-Related Current Pathway
1
Electrical Component
2
Electrical Interconnect
1
Other
1
Malfunctions (WW)
Therapy Function Not Compromised
48
Battery
28
Device-Related Current Pathway
1
Electrical Component
15
Software/Firmware
1
Other
3
Therapy Function Compromised
35
Battery
30
Device-Related Current Pathway
1
Electrical Component
2
Electrical Interconnect
1
Other
1
EOS Indication
From the point that the RRT is set, the pacemaker will operate for approximately three months for typical pacemaker configurations during the normal operating life.
Recommended Replacement (RRT)
Battery voltage less than or equal to 2.73V on 3 consecutive daily automatic measurments.
