SED01 Sensia D
Implantable Pulse Generator (IPG)
SED01 Sensia D
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 at 128.0 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 99.4 98.8 97.2 90.4 73.2 51.5 43.2                    
#   127373 117060 103788 90028 75951 61746 47121 31171 13972 3409 321                    
  • 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 NWK, PWK
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 SED01 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 Implants7
Estimated Active USA Implants3
Normal Battery Depletions1
US Market Release2006-07-17
CE Approval Date2005-09-20
Estimated WW Distribution51817
Normal Battery Depletions36
Information

Malfunctions (USA)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Malfunctions (WW)

Therapy Function Not Compromised 4
Electrical Component 4
Therapy Function Compromised 2
Electrical Component 2
Information

EOS Indication

Prolonged service period is 3 months after RRT/ERI assuming 100% VVI 65 ppm pacing at the listed parameter settings. Reprogramming of parameters can reduce 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 January 31, 2018

www.medtronic.com/productperformance 601051