SPDRL1 Sphera L DR MRI
Implantable Pulse Generator (IPG)
SPDRL1 Sphera L DR MRI
Information

Device Survival Probability

ATDRL1_SPDRL1_SURV
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    at 0.0 mo                  
  • 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.
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Customer Communications For This Model

Information

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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IS-1 UNI/BI
Information

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
Footnote

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 %; Upper Sensing Rate 130 ppm; Atrial Percent Paced 100 %; Atrial Fib Percent of Time 0 % Hide this content

Information

Distribution Data

US Market Release2017-08-03
CE Approval Date2017-06-16
Registered USA Implants
Estimated Active USA Implants
Normal Battery Depletions
US Market Release2017-08-03
CE Approval Date2017-06-16
Estimated WW Distribution4661
Normal Battery Depletions
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Malfunctions (USA)

Therapy Function Not Compromised
Therapy Function Compromised
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Malfunctions (WW)

Therapy Function Not Compromised
Therapy Function Compromised
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EOL Indicator

180 days from RRT

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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 October 29, 2020

www.medtronic.com/productperformance 776050