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 at 111.0 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 99.9 99.8 99.7 99.4 98.6 96.2 84.2 60.2 46.8
#   120293 103503 86596 70113 54102 38889 24059 10223 1301 142
  • 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 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

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

Distribution Data

US Market Release2006-07-17
CE Approval Date2005-09-20
Registered USA Implants147732
Estimated Active USA Implants91297
Normal Battery Depletions3162
US Market Release2006-07-17
CE Approval Date2005-09-20
Estimated WW Distribution492864
Normal Battery Depletions3410
Information

Malfunctions (USA)

Therapy Function Not Compromised 16
Battery 1
Electrical Component 13
Electrical Interconnect 1
Other 1
Therapy Function Compromised 14
Electrical Component 6
Electrical Interconnect 3
Other 5
Information

Malfunctions (WW)

Therapy Function Not Compromised 47
Battery 1
Electrical Component 41
Electrical Interconnect 1
Other 4
Therapy Function Compromised 22
Electrical Component 13
Electrical Interconnect 4
Other 5
Information

Recommended Replacement (RRT)

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

Data as of April 14, 2016

www.medtronic.com/productperformance 426050