SPDRL1 Sphera L DR MRI
Implantable Pulse Generator (IPG)
Device Survival Probability
ATDRL1_SPDRL1_SURV
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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.
Customer Communications For This Model
Product Characteristics
Generator Type
IPG
NBD Code
DDDR
Max. Delivered Energy
N/A
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Connector Style
IS-1 UNI/BI
Serial Number Prefix
FND
Mass
31.3 g
Volume
13.1 cc
Waveform
N/A
X-Ray ID
PHX
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Estimated Longevity
Amplitude Setting
500 Lead Ω
1000 Lead Ω
Low 2.5 V (A, RV)
11.6
13.3
Nominal 3.5 V (A, RV)
9.0
11.5
High 5.0 V (A, RV)
6.3
8.8
USA
WW
Distribution Data
US Market Release 2017-08-03
CE Approval Date 2017-06-16
Registered USA Implants
Estimated Active USA Implants
Normal Battery Depletions
US Market Release 2017-08-03
CE Approval Date 2017-06-16
Estimated WW Distribution 8930
Normal Battery Depletions
Malfunctions (USA)
Therapy Function Not Compromised
Therapy Function Compromised
Malfunctions (WW)
Therapy Function Not Compromised
Therapy Function Compromised
EOL Indicator
180 days from RRT
Recommended Replacement (RRT)
Battery voltage less than or equal to 2.5 V, or battery voltage less than or equal to 2.59 V and battery impedance at 3000 ohms
Data as of December 16, 2021