ADDRL1 Adapta L DR
Implantable Pulse Generator (IPG)
ADDRL1 Adapta L DR
Information

Device Survival Probability

ADDRL1_SEDRL1_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 11 yr 12 yr at 145.0 mo                
% Excluding Normal Battery Depletion 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0                
% Including Normal Battery Depletion 99.9 99.9 99.9 99.8 99.6 99.4 99.2 98.8 98.0 95.4 86.9 55.6 46.3                
#   120580 113291 106127 97300 85809 72907 59763 45402 32014 19983 9552 941 340                
  • 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

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 PWE, NWE
Mass 31.3 g
Volume 13.1 cc
Waveform N/A
X-Ray ID PWB, NWE
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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) 9.0 | 11.1* 10.0 | 12.6*
Nominal 3.5 V (A, RV) 7.3 | 8.7* 8.9 | 11.0*
High 5.0 V (A, RV) 5.4 | 6.1* 7.2 | 8.5*
Footnote

*The second longevity numbers provided apply to the N-series Adapta ADDRL1 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

Distribution Data

US Market Release2006-07-17
CE Approval Date2005-09-20
Registered USA Implants138548
Estimated Active USA Implants75361
Normal Battery Depletions2788
US Market Release2006-07-17
CE Approval Date2005-09-20
Estimated WW Distribution306585
Normal Battery Depletions3371
Information

Malfunctions (USA)

Therapy Function Not Compromised 16
Electrical Component 13
Electrical Interconnect 1
Possible Early Battery Depletion 2
Therapy Function Compromised 7
Electrical Component 4
Electrical Interconnect 1
Other 2
Information

Malfunctions (WW)

Therapy Function Not Compromised 41
Electrical Component 37
Electrical Interconnect 2
Possible Early Battery Depletion 2
Therapy Function Compromised 18
Electrical Component 15
Electrical Interconnect 1
Other 2
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