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 at 175.0 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 99.2 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 82.3 70.8 54.6 39.5 26.9 16.6            
#   88298 78253 69207 60878 53401 46768 40570 35095 30115 23984 17015 9831 4679 1315 148            
  • 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.

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 Implants94
Normal Battery Depletions161
US Market Release1999-08-30
CE Approval Date1998-12-17
Estimated WW Distribution2416
Normal Battery Depletions173
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 February 3, 2017

www.medtronic.com/productperformance 476050