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 10 yr at 122.0 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 99.8 99.7 99.6 99.2 98.7 97.9 95.9 89.8 72.8 44.8 34.2                    
#   86467 76337 67811 59102 50628 41086 31239 20994 10218 1732 593                    
  • 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

  • There are no communications 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

Distribution Data

US Market Release2006-07-17
CE Approval Date2005-09-20
Registered USA Implants117244
Estimated Active USA Implants52622
Normal Battery Depletions5626
US Market Release2006-07-17
CE Approval Date2005-09-20
Estimated WW Distribution515098
Normal Battery Depletions6691
Information

Malfunctions (USA)

Therapy Function Not Compromised 12
Electrical Component 7
Possible Early Battery Depletion 4
Other 1
Therapy Function Compromised 4
Electrical Component 3
Electrical Interconnect 1
Information

Malfunctions (WW)

Therapy Function Not Compromised 23
Electrical Component 14
Possible Early Battery Depletion 7
Other 2
Therapy Function Compromised 12
Electrical Component 11
Electrical Interconnect 1
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

Recommended Replacement (RRT)

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

Data as of October 29, 2020

www.medtronic.com/productperformance 776050