ADD01 Adapta D
Implantable Pulse Generator (IPG)
ADD01 Adapta D
Information

Device Survival Probability

ADDR01_ADDR03_ADDR06_ADD01_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 121.0 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 99.9 99.9 99.8 99.7 99.5 99.0 97.7 91.4 71.4 31.7 24.7                    
#   402550 365056 327198 281707 234582 186941 139988 88426 35105 2976 1408                    
  • 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 DDD
Max. Delivered Energy N/A
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Connector Style IS-1 UNI/BI
Serial Number Prefix PWF, NWF
Mass 27.1 g
Volume 12.1 cc
Waveform N/A
X-Ray ID PWB, NWF
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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 | 9.1* 8.2 | 10.3*
Nominal 3.5 V (A, RV) 6.0 | 7.2* 7.4 | 9.0*
High 5.0 V (A, RV) 4.5 | 5.1* 6.0 | 7.0*
Footnote

*The second longevity numbers provided apply to the N-series Adapta ADD01 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

The 3 month prolonged service period between RRT/ERI and EOS assumes 100% pacing in VVI mode, rate of 65 ppm, RV Amplitude of 3.5 V, RV Pulse Width of 0.4 ms, and pacing load of 500 OHMS;. Reprogramming the pacing parameters may reduce the duration of the prolonged service period.

Information

Distribution Data

US Market Release2006-07-17
CE Approval Date2005-09-20
Registered USA Implants
Estimated Active USA Implants
Normal Battery Depletions
US Market Release2006-07-17
CE Approval Date2005-09-20
Estimated WW Distribution29211
Normal Battery Depletions39
Information

Malfunctions (USA)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Malfunctions (WW)

Therapy Function Not Compromised 1
Electrical Component 1
Therapy Function Compromised 0
Information

Recommended Replacement (RRT)

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

Data as of July 31, 2017

www.medtronic.com/productperformance 501050