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 VVI ;
Right Ventricle Pulse Width 0.4 ms;
Lower Pace Rate 60 bpm;
Right Ventricle Percent Paced 100 %;
Upper Sensing Rate 130 ppmHide this content
Distribution Data
US Market Release
1999-08-30
CE Approval Date
1998-12-17
Registered USA Implants
51767
Estimated Active USA Implants
1810
Normal Battery Depletions
3118
US Market Release
1999-08-30
CE Approval Date
1998-12-17
Estimated WW Distribution
126876
Normal Battery Depletions
3609
Malfunctions (USA)
Therapy Function Not Compromised
12
Electrical Interconnect
10
Software/Firmware
1
Other
1
Therapy Function Compromised
46
Electrical Component
3
Electrical Interconnect
43
Malfunctions (WW)
Therapy Function Not Compromised
38
Electrical Component
5
Electrical Interconnect
30
Software/Firmware
1
Other
2
Therapy Function Compromised
202
Electrical Component
5
Electrical Interconnect
195
Software/Firmware
1
Other
1
EOL Indication
3 months after ERI.
Elective Replacement (ERI)
Telemetry indication. Rate and Mode change to 65 ppm and VVI (VOO/65 with magnet).