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 176.0 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 99.3 99.3 99.2 99.2 99.2            
% Including Normal Battery Depletion 99.6 99.5 99.3 99.0 98.6 97.8 96.7 93.9 89.4 82.0 70.5 54.0 37.1 22.6 7.3            
#   87010 77034 68064 59823 52406 45829 39677 34247 29397 24438 18721 11432 5718 1925 135            
  • 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 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

Distribution Data

US Market Release1999-08-30
CE Approval Date1998-12-17
Registered USA Implants1200
Estimated Active USA Implants77
Normal Battery Depletions168
US Market Release1999-08-30
CE Approval Date1998-12-17
Estimated WW Distribution2416
Normal Battery Depletions181
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

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

Elective Replacement (ERI)

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

Data as of November 8, 2019

www.medtronic.com/productperformance 726050