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.
Information

Advisories For This Model

Performance Notes For This Model

    • There are no performance notes 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 Distribution1171
Normal Battery Depletions
Information

Malfunctions (USA)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Malfunctions (WW)

Therapy Function Not Compromised
Therapy Function Compromised
Information

EOL Indication

180 days from RRT

Information

Recommended Replacement (RRT)

≤2.5V, or ≤ 2.59V and battery impedance at ≥ 3000Ω

Data as of October 12, 2018

www.medtronic.com/productperformance 626050