SEDR01 Sensia DR
Implantable Pulse Generator (IPG)
SEDR01 Sensia DR
Information

Device Survival Probability

SEDR01_SED01_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 at 138.0 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                  
% Including Normal Battery Depletion 99.9 99.9 99.8 99.6 99.4 98.8 97.5 92.2 79.4 63.8 57.4 55.6                  
#   127419 118153 109210 97378 84938 71681 57868 41918 24241 9403 2292 283                  
  • 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

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 NWL, PWL
Mass 27.1 g
Volume 12.1 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) 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 Sensia SEDR01 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 Implants149332
Estimated Active USA Implants78675
Normal Battery Depletions8103
US Market Release2006-07-17
CE Approval Date2005-09-20
Estimated WW Distribution608021
Normal Battery Depletions8447
Information

Malfunctions (USA)

Therapy Function Not Compromised 17
Electrical Component 15
Electrical Interconnect 1
Other 1
Therapy Function Compromised 15
Electrical Component 6
Electrical Interconnect 3
Possible Early Battery Depletion 1
Other 5
Information

Malfunctions (WW)

Therapy Function Not Compromised 48
Electrical Component 43
Electrical Interconnect 1
Other 4
Therapy Function Compromised 23
Electrical Component 13
Electrical Interconnect 4
Possible Early Battery Depletion 1
Other 5
Information

EOS Indication

The prolonged service period is 3 months after RRT/ERI and assumes 100% pacing at VVI/65 and the listed parameter values. Reprogramming of parameters may shorten the duration of the prolonged service period.

Information

Recommended Replacement (RRT)

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

Data as of April 11, 2019

www.medtronic.com/productperformance 651050