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 at 93.0 mo    
% Excluding Normal Battery Depletion 100.0 100.0 100.0 100.0 100.0 100.0 100.0 99.9    
% Including Normal Battery Depletion 100.0 99.9 99.8 99.4 98.7 97.2 92.5 81.5    
#   67340 52168 39196 28316 19119 10996 4137 309    
  • 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 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

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

Distribution Data

US Market Release2006-07-17
CE Approval Date2005-09-20
Registered USA Implants73978
Estimated Active USA Implants52488
Normal Battery Depletions476
US Market Release2006-07-17
CE Approval Date2005-09-20
Estimated WW Distribution165930
Normal Battery Depletions664
Information

Malfunctions (USA)

Therapy Function Not Compromised 6
Electrical Component 4
Electrical Interconnect 1
Possible Early Battery Depletion 1
Therapy Function Compromised 4
Electrical Component 3
Electrical Interconnect 1
Information

Malfunctions (WW)

Therapy Function Not Compromised 17
Electrical Component 13
Electrical Interconnect 2
Possible Early Battery Depletion 1
Other 1
Therapy Function Compromised 6
Electrical Component 5
Electrical Interconnect 1
Information

Recommended Replacement (RRT)

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

Data as of August 3, 2014

www.medtronic.com/productperformance 326050