ATSR01 Attesta SR MRI
Implantable Pulse Generator (IPG)
ATSR01 Attesta SR MRI
Information

Device Survival Probability

ATTESTA_SR_SURV
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    at 2.0 mo                  
% Excluding Normal Battery Depletion 100.0                  
% Including Normal Battery Depletion 100.0                  
#   106                  
  • 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

Customer Communications For This Model

  • There are no communications for this model.
Information

Product Characteristics

Generator Type IPG
NBD Code AAIR/VVIR, AAI/VVI
Max. Delivered Energy NA
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Connector Style IS-1 UNI/BI
Serial Number Prefix FNF
Mass 21.5 g
Volume 9.7 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) 9.4 10.3
Nominal 3.5 V (A, RV) 8.1 9.7
High 5.0 V (A, RV) 6.1 7.8
Footnote

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 ppm; Hide this content

Information

Distribution Data

US Market Release2017-08-03
CE Approval Date2017-06-16
Registered USA Implants136
Estimated Active USA Implants123
Normal Battery Depletions
US Market Release2017-08-03
CE Approval Date2017-06-16
Estimated WW Distribution22134
Normal Battery Depletions
Information

Malfunctions (USA)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Malfunctions (WW)

Therapy Function Not Compromised 1
Electrical Component 1
Therapy Function Compromised 0
Information

EOL Indicator

180 days from RRT

Information

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 11, 2021

www.medtronic.com/productperformance 826050