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 SEDR01 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
149410
Estimated Active USA Implants
28126
Normal Battery Depletions
17253
US Market Release
2006-07-17
CE Approval Date
2005-09-20
Estimated WW Distribution
663885
Normal Battery Depletions
17739
Malfunctions (USA)
Therapy Function Not Compromised
17
Electrical Component
15
Electrical Interconnect
1
Other
1
Therapy Function Compromised
16
Electrical Component
6
Electrical Interconnect
3
Possible Early Battery Depletion
1
Other
6
Malfunctions (WW)
Therapy Function Not Compromised
51
Electrical Component
44
Electrical Interconnect
1
Possible Early Battery Depletion
2
Other
4
Therapy Function Compromised
26
Electrical Component
15
Electrical Interconnect
4
Possible Early Battery Depletion
1
Other
6
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).
