SESR01 Sensia SR
Implantable Pulse Generator (IPG)
SESR01 Sensia SR
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 109.0 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 99.9 99.8 99.7 99.4 98.9 98.1 95.4 85.1 34.8 3.0
#   87750 75457 62100 49348 37821 27116 17705 8607 552 117
  • 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 SSIR
Max. Delivered Energy N/A
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Connector Style IS-1 UNI/BI
Serial Number Prefix PWR, NWR
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 SESR01 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 month; 100% pacing and pulse width 0.4 ms.Hide this content

Information

EOS Indication

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

Information

Distribution Data

US Market Release2006-07-17
CE Approval Date2005-09-20
Registered USA Implants115836
Estimated Active USA Implants62730
Normal Battery Depletions3229
US Market Release2006-07-17
CE Approval Date2005-09-20
Estimated WW Distribution446299
Normal Battery Depletions4104
Information

Malfunctions (USA)

Therapy Function Not Compromised 9
Electrical Component 8
Other 1
Therapy Function Compromised 3
Electrical Component 2
Electrical Interconnect 1
Information

Malfunctions (WW)

Therapy Function Not Compromised 19
Electrical Component 14
Possible Early Battery Depletion 3
Other 2
Therapy Function Compromised 11
Electrical Component 10
Electrical Interconnect 1
Information

Recommended Replacement (RRT)

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

Data as of July 31, 2017

www.medtronic.com/productperformance 501050