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 12 yr at 154.0 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 99.8 99.8 99.6 99.5 99.1 98.4 97.0 91.8 79.8 64.5 51.1 40.1 33.2                
#   121523 109947 99333 89731 80883 70888 59895 46737 31794 18631 9143 3142 124                
  • 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 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 Implants149368
Estimated Active USA Implants37890
Normal Battery Depletions12071
US Market Release2006-07-17
CE Approval Date2005-09-20
Estimated WW Distribution654034
Normal Battery Depletions12497
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 51
Electrical Component 44
Electrical Interconnect 1
Possible Early Battery Depletion 2
Other 4
Therapy Function Compromised 25
Electrical Component 15
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 October 11, 2021

www.medtronic.com/productperformance 826050