SDR306 Sigma 300 DR
Implantable Pulse Generator (IPG)
SDR306 Sigma 300 DR
Information

Device Survival Probability

SDR303_SDR306_SD303_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 13 yr 14 yr 15 yr at 181.0 mo          
% Excluding Normal Battery Depletion 100.0 100.0 100.0 99.9 99.9 99.8 99.7 99.6 99.5 99.4 99.4 99.3 99.3 99.2 99.2 99.2          
% Including Normal Battery Depletion 99.7 99.6 99.4 99.1 98.7 98.0 96.8 94.1 89.7 82.4 71.1 55.7 41.1 29.9 20.1 18.5          
#   88289 78246 69203 60876 53402 46771 40573 35097 30208 25063 18681 11478 6028 2495 294 164          
  • 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 DDD/RO
Max. Delivered Energy N/A
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Connector Style 5/6mm UNI
Serial Number Prefix PJE
Mass 27.0 g
Volume 15.9 cc
Waveform N/A
X-Ray ID PJE
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5/6mm UNI
Information

Estimated Longevity

Amplitude Setting 500 Lead Ω 1000 Lead Ω
Low 2.5 V (A, RV) 10.1 11.7
Nominal 3.5 V (A, RV) 7.5 9.6
High 5.0 V (A, RV) 5.5 7.8
Footnote

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 %; Upper Sensing Rate 130 ppm; Atrial Percent Paced 100 %; Atrial Fib Percent of Time 0 %Hide this content

Information

EOL Indication

From the point that the ERI is set, the pacemaker will operate at ERI conditions for approximately three months for typical pacemaker configurations during the normal operating life.

Information

Distribution Data

US Market Release1999-08-30
CE Approval Date1998-12-17
Registered USA Implants1209
Estimated Active USA Implants85
Normal Battery Depletions165
US Market Release1999-08-30
CE Approval Date1998-12-17
Estimated WW Distribution2416
Normal Battery Depletions177
Information

Malfunctions (USA)

Therapy Function Not Compromised 0
Therapy Function Compromised 5
Electrical Interconnect 5
Information

Malfunctions (WW)

Therapy Function Not Compromised 2
Electrical Interconnect 2
Therapy Function Compromised 6
Electrical Interconnect 6
Information

Elective Replacement (ERI)

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