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 %;
EGM Prestorage ON ;
Upper Sensing Rate 130 ppm;
Atrial Percent Paced 100 %;
EGM Prestorage ON Time 1 month;
Atrial Fib Percent of Time 0 %Hide this content
Distribution Data
US Market Release
CE Approval Date
2008-05-07
Registered USA Implants
1
Estimated Active USA Implants
0
Normal Battery Depletions
US Market Release
CE Approval Date
2008-05-07
Estimated WW Distribution
39509
Normal Battery Depletions
22
Malfunctions (USA)
Therapy Function Not Compromised
Therapy Function Compromised
Malfunctions (WW)
Therapy Function Not Compromised
2
Electrical Component
1
Possible Early Battery Depletion
1
Therapy Function Compromised
1
Electrical Component
1
EOS Indication
The prolonged service period is 3 months after RRT/ERI and assumes 100% pacing at VVI/65 and the listed parameter values. Reprogramming of parameters may shorten the duration of the prolonged service period.
Recommended Replacement (RRT)
Telemetry indication. Rate and Mode change to 65 ppm and VVI (VOO/65 with magnet).
