ADDRS1 Adapta DR
Implantable Pulse Generator (IPG)
ADDRS1 Adapta DR
Information

Device Survival Probability


ADDRS1_SURV
    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr at 80 mo      
% Excluding Normal Battery Depletion 100.0 100.0 100.0 100.0 100.0 99.9 99.9      
% Including Normal Battery Depletion 99.9 99.8 99.6 98.7 95.6 81.6 49.4      
#   30870 24046 17830 12030 6970 2462 263      
  • 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

Information

Product Characteristics

Generator Type IPG
NBD Code DDDR
Max. Delivered Energy N/A
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Connector Style IS-1 UNI/BI
Serial Number Prefix PWA, NWA
Mass 23.6 g
Volume 11.1 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) 5.5 | 6.9* 6.1 | 7.8*
Nominal 3.5 V (A, RV) 4.3 | 5.3* 5.4 | 6.8*
High 5.0 V (A, RV) 3.2 | 3.7* 4.4 | 5.2*
Footnote

*The second longevity numbers provided apply to the N-series Adapta ADDRS1 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 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

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 Implants37390
Estimated Active USA Implants27249
Normal Battery Depletions807
US Market Release2006-07-17
CE Approval Date2005-09-20
Estimated WW Distribution61132
Normal Battery Depletions819
Information

Malfunctions (USA)

Therapy Function Not Compromised 6
Electrical Component 5
Possible Early Battery Depletion 1
Therapy Function Compromised 4
Electrical Component 2
Other 2
Information

Malfunctions (WW)

Therapy Function Not Compromised 10
Electrical Component 9
Possible Early Battery Depletion 1
Therapy Function Compromised 7
Electrical Component 5
Other 2
Information

Recommended Replacement (RRT)

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

Data as of January 31, 2014

www.medtronic.com/productperformance 301050