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
1999-09-15
CE Approval Date
1998-12-17
Registered USA Implants
165
Estimated Active USA Implants
12
Normal Battery Depletions
US Market Release
1999-09-15
CE Approval Date
1998-12-17
Estimated WW Distribution
46257
Normal Battery Depletions
133
Malfunctions (USA)
Therapy Function Not Compromised
Therapy Function Compromised
Malfunctions (WW)
Therapy Function Not Compromised
8
Electrical Component
2
Electrical Interconnect
5
Possible Early Battery Depletion
1
Therapy Function Compromised
24
Electrical Component
1
Electrical Interconnect
22
Possible Early Battery Depletion
1
EOL Indication
From the point that the ERI is set, the pacemaker will operate at ERI conditions for approximately three months for typical pacemaker configurations during the normal operating life.
