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 at 101.0 mo  
% Excluding Normal Battery Depletion 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0  
% Including Normal Battery Depletion 99.9 99.9 99.7 99.3 98.6 97.1 91.7 70.3 34.2  
#   67587 53445 41190 30405 21645 14493 8006 2164 291  
  • 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 Implants85833
Estimated Active USA Implants52457
Normal Battery Depletions1596
US Market Release2006-07-17
CE Approval Date2005-09-20
Estimated WW Distribution192061
Normal Battery Depletions2061
Information

Malfunctions (USA)

Therapy Function Not Compromised 7
Electrical Component 5
Electrical Interconnect 1
Possible Early Battery Depletion 1
Therapy Function Compromised 6
Electrical Component 5
Electrical Interconnect 1
Information

Malfunctions (WW)

Therapy Function Not Compromised 18
Electrical Component 14
Electrical Interconnect 2
Possible Early Battery Depletion 1
Other 1
Therapy Function Compromised 9
Electrical Component 8
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 April 14, 2016

www.medtronic.com/productperformance 426050