SEDRL1 Sensia L DR
Implantable Pulse Generator (IPG)
SEDRL1 Sensia 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 at 127.0 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 100.0 99.9 99.9 99.8 99.7 99.5 99.3 98.9 97.8 91.5 63.9                    
#   122151 114496 104223 91227 76804 60075 43597 28405 16045 5504 572                    
  • 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

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 NWJ, PWJ
Mass 31.3 g
Volume 13.1 cc
Waveform N/A
X-Ray ID PWL, 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) 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 Sensia SEDRL1 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 Implants3
Estimated Active USA Implants2
Normal Battery Depletions
US Market Release2006-07-17
CE Approval Date2005-09-20
Estimated WW Distribution134293
Normal Battery Depletions231
Information

Malfunctions (USA)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Malfunctions (WW)

Therapy Function Not Compromised 6
Electrical Component 5
Other 1
Therapy Function Compromised 4
Electrical Component 4
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 (VOO/65 with magnet).

Data as of November 8, 2019

www.medtronic.com/productperformance 726050