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.
*The second longevity numbers provided apply to the N-series Versa VEDR01 product. The N-series products have increased longevity because of improved electronic circuitry. Click on "Other Articles" for more information on the N-series longevity.
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 ;
Atrial Fib Percent of Time 0 %Hide this content
Distribution Data
US Market Release
2006-07-17
CE Approval Date
2005-09-20
Registered USA Implants
118955
Estimated Active USA Implants
24936
Normal Battery Depletions
14225
US Market Release
2006-07-17
CE Approval Date
2005-09-20
Estimated WW Distribution
178057
Normal Battery Depletions
14254
Malfunctions (USA)
Therapy Function Not Compromised
11
Electrical Component
7
Electrical Interconnect
2
Possible Early Battery Depletion
2
Therapy Function Compromised
14
Electrical Component
10
Other
4
Malfunctions (WW)
Therapy Function Not Compromised
18
Electrical Component
14
Electrical Interconnect
2
Possible Early Battery Depletion
2
Therapy Function Compromised
19
Electrical Component
14
Electrical Interconnect
1
Other
4
EOS Indication
Prolonged Service period is 3 months after RRT/ERI assuming 100% pacing at the listed parameter settings. Reprogramming of pacing parameters may reduce 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).
