A5DR01 Advisa DR
Implantable Pulse Generator (IPG)
A5DR01 Advisa DR
Information

Device Survival Probability

A2DR01_A3DR01_A5DR01_EN1DR01_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr at 69.0 mo        
% Excluding Normal Battery Depletion 100.0 100.0 100.0 100.0 100.0 100.0        
% Including Normal Battery Depletion 100.0 100.0 99.9 99.9 99.9 99.9        
#   207718 122534 52911 14877 659 110        
  • 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 OAE-DDDR
Max. Delivered Energy N/A
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Connector Style IS-1 UNI/BI
Serial Number Prefix PZL
Mass 22g
Volume 12.7cc
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) 8.9 10.2
Nominal 3.5 V (A, RV) 6.9 8.6
High 5.0 V (A, RV) 4.3 6.2
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 %; EGM Prestorage ON ; Upper Sensing Rate 130 ppm; Atrial Percent Paced 100 %; EGM Prestorage ON Time 1 ; Atrial Fib Percent of Time 0 %; 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 Release
CE Approval Date2009-06-02
Registered USA Implants1
Estimated Active USA Implants1
Normal Battery Depletions
US Market Release
CE Approval Date2009-06-02
Estimated WW Distribution29222
Normal Battery Depletions
Information

Malfunctions (USA)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Malfunctions (WW)

Therapy Function Not Compromised 18
Battery 16
Electrical Component 2
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 July 31, 2017

www.medtronic.com/productperformance 501050