SES01 Sensia S
Implantable Pulse Generator (IPG)
SES01 Sensia S
Information

Device Survival Probability

SESR01_SES01_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr at 116.0 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
% Including Normal Battery Depletion 99.8 99.8 99.6 99.4 98.9 98.1 96.1 89.1 67.6 36.8
#   88915 78281 68550 58012 46734 36222 26059 15504 5498 417
  • 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

    • There are no performance notes for this model.
Information

Product Characteristics

Generator Type IPG
NBD Code SSI
Max. Delivered Energy N/A
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Connector Style IS-1 UNI/BI
Serial Number Prefix PWS, NWS
Mass 21.5 g
Volume 9.7 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 | 8.9* 7.9 | 9.7*
Nominal 3.5 V (A, RV) 6.5 | 7.7* 7.5 | 9.1*
High 5.0 V (A, RV) 5.1 | 5.9* 6.3 | 7.4*
Footnote

*The second longevity numbers provided apply to the N-series Sensia SES01 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 VVI ; 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; EGM Prestorage ON Time 1 monthHide this content

Information

Distribution Data

US Market Release2006-07-17
CE Approval Date2005-09-20
Registered USA Implants8
Estimated Active USA Implants2
Normal Battery Depletions
US Market Release2006-07-17
CE Approval Date2005-09-20
Estimated WW Distribution75745
Normal Battery Depletions102
Information

Malfunctions (USA)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Malfunctions (WW)

Therapy Function Not Compromised 2
Electrical Component 2
Therapy Function Compromised 4
Battery 1
Electrical Component 3
Information

EOS Indication

Prolonged service period is 3 months after RRT/ERI assuming 100% pacing at VVI/65 ppm at the listed parameter settings. Reprogramming of parameter settings 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