ADSR01 Adapta SR
Implantable Pulse Generator (IPG)
ADSR01 Adapta SR
Information

Device Survival Probability

ADSR01_ADSR03_ADSR06_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr 10 yr at 123.0 mo                    
% Excluding Normal Battery Depletion 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0                    
% Including Normal Battery Depletion 99.7 99.5 99.3 98.8 98.0 96.8 93.7 85.2 61.3 29.8 6.1                    
#   73375 63732 55418 47660 40189 33193 24921 16212 7313 1210 120                    
  • 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 SSIR
Max. Delivered Energy N/A
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Connector Style IS-1 UNI/BI
Serial Number Prefix NWM, PWM
Mass 21.5 g
Volume 9.7 cc
Waveform N/A
X-Ray ID PWB
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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) 7.4 | 8.9* 7.9 | 9.7*
Nominal 3.5 V (A, RV) 6.5 | 7.7* 7.5 | 9.1*
High 5.0 V (A, RV) 5.1 | 5.9* 6.3 | 7.4*
Footnote

*The second longevity numbers provided apply to the N-series Adapta ADSR01 product. The N-series products have increased longevity because of improved electronic circuitry. Click on "Other Articles" for more information on the N-series longevity. 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

Distribution Data

US Market Release2006-07-17
CE Approval Date2005-09-20
Registered USA Implants93422
Estimated Active USA Implants24148
Normal Battery Depletions4841
US Market Release2006-07-17
CE Approval Date2005-09-20
Estimated WW Distribution249596
Normal Battery Depletions5435
Information

Malfunctions (USA)

Therapy Function Not Compromised 11
Electrical Component 6
Electrical Interconnect 1
Possible Early Battery Depletion 4
Therapy Function Compromised 6
Electrical Component 5
Electrical Interconnect 1
Information

Malfunctions (WW)

Therapy Function Not Compromised 24
Electrical Component 17
Electrical Interconnect 2
Possible Early Battery Depletion 4
Software/Firmware 1
Therapy Function Compromised 9
Electrical Component 8
Electrical Interconnect 1
Information

EOS Indication

From the point that the ERI is set, the pacemaker will operate at ERI conditions for approximately three months for typical pacemaker configurations during the normal operating life.

Information

Recommended Replacement (RRT)

Telemetry indication. Rate and mode change to 65 ppm and VVI respectively (VOO/65 with magnet).

Data as of October 11, 2021

www.medtronic.com/productperformance 826050