A3SR01 Advisa SR MRI
Implantable Pulse Generator (IPG)
A3SR01 Advisa SR MRI
Information

Device Survival Probability

A3SR01_ENSR01_SURV
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    1 yr at 20.0 mo                
% Excluding Normal Battery Depletion 100.0 100.0                
% Including Normal Battery Depletion 100.0 100.0                
#   4191 198                
  • 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

  • There are no 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 VVIR
Max. Delivered Energy N/A
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Connector Style IS-1 UNI/BI
Serial Number Prefix PTR
Mass 21 g
Volume 11.9 cc
Waveform N/A
X-Ray ID PVX
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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) 11.9 12.9
Nominal 3.5 V (A, RV) 10.0 11.6
High 5.0 V (A, RV) 7.8 9.8
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 %; EGM Prestorage ON ; Upper Sensing Rate 130 ppm; EGM Prestorage ON Time 1 ; Hide this content

Information

EOS Indication

The Prolonged Service Period (PSP) is the time between the RRT and EOS. The PSP is defined as 6 months assuming the following conditions: 100% VVI pacing at 60 min–1, 2.5 V RV pacing amplitude; 0.4 ms pulse width; and 600 Ω pacing load. The EOS may be indicated before the end of 6 months if the device exceeds these conditions.

Information

Distribution Data

US Market Release2015-03-19
CE Approval Date2014-04-24
Registered USA Implants14342
Estimated Active USA Implants13773
Normal Battery Depletions
US Market Release2015-03-19
CE Approval Date2014-04-24
Estimated WW Distribution37398
Normal Battery Depletions
Information

Malfunctions (USA)

Therapy Function Not Compromised 2
Electrical Component 1
Possible Early Battery Depletion 1
Therapy Function Compromised 0
Information

Malfunctions (WW)

Therapy Function Not Compromised 3
Electrical Component 2
Possible Early Battery Depletion 1
Therapy Function Compromised 0
Information

Recommended Replacement (RRT)

Battery voltage less than or equal to 2.83V on 3 consecutive daily automatic measurments.

Data as of February 3, 2017

www.medtronic.com/productperformance 476050