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 service life projection for the device is 11.7 years. This projection is an estimate of the average expected service life based on the following assumptions: Pacing at 0%; 2 high-voltage therapies per year; Pre-arrhythmia EGM storage programmed to On for 6-months, over life of device; Wireless telemetry: 3 hours of telemetry enabled at implant, 30 min of telemetry enabled for quarterly scheduled CareLink Monitor remote sessions (if available), 1 hour of in-office wireless telemetry enabled annually; Shelf storage life of 5 months, before implant.Hide this content
Distribution Data
US Market Release
2023-10-20
CE Approval Date
2023-02-17
Registered USA Implants
1661
Estimated Active USA Implants
1614
Normal Battery Depletions
US Market Release
2023-10-20
CE Approval Date
2023-02-17
Estimated WW Distribution
4223
Normal Battery Depletions
Malfunctions (USA)
Therapy Function Not Compromised
Therapy Function Compromised
Malfunctions (WW)
Therapy Function Not Compromised
Therapy Function Compromised
EOS Indicator
From the point that the RRT is set, the device will operate for approximately three months for typical device configurations during the normal operating life.
Recommended Replacement (RRT)
Battery voltage less than 2.73 V on 3 consecutive daily automatic measurements.
