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 Sensia SESR01 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 VVI ;
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;
EGM Prestorage ON Time 1 month;
100% pacing and pulse width 0.4 ms.Hide this content
Distribution Data
US Market Release
2006-07-17
CE Approval Date
2005-09-20
Registered USA Implants
117372
Estimated Active USA Implants
21421
Normal Battery Depletions
8890
US Market Release
2006-07-17
CE Approval Date
2005-09-20
Estimated WW Distribution
551421
Normal Battery Depletions
10035
Malfunctions (USA)
Therapy Function Not Compromised
13
Electrical Component
7
Possible Early Battery Depletion
4
Other
2
Therapy Function Compromised
4
Electrical Component
3
Electrical Interconnect
1
Malfunctions (WW)
Therapy Function Not Compromised
26
Electrical Component
16
Possible Early Battery Depletion
7
Other
3
Therapy Function Compromised
12
Electrical Component
11
Electrical Interconnect
1
EOS Indication
Prolonged service period is 3 months after RRT/ERI assuming 100% VVI/65 ppm pacing at the listed parameter settings. Reprogramming 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).
