P1501DR EnRhythm DR
Implantable Pulse Generator (IPG)
P1501DR EnRhythm DR
Information

Device Survival Probability

P1501DR_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 123.0 mo                    
% Excluding Normal Battery Depletion 99.9 99.9 99.7 98.0 93.7 87.1 81.7 77.8 75.3 74.8 74.8                    
% Including Normal Battery Depletion 99.7 99.6 99.1 96.7 90.3 78.3 63.2 46.6 30.3 11.5 3.9                    
#   95559 89225 83187 76172 66157 52138 36404 20803 9403 1883 379                    
  • 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 DDDRP
Max. Delivered Energy N/A
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Connector Style IS-1 UNI/BI
Serial Number Prefix PNP
Mass 21.0 g
Volume 13.0 cc
Waveform N/A
X-Ray ID PNP
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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) 9.7 11.2
Nominal 3.5 V (A, RV) 7.3 9.4
High 5.0 V (A, RV) 4.9 7.1
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 %; These estimates are adjusted to reflect changes addressed by February 2010 Advisory "Low Battery Voltage Displayed at Device Interrogation".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 Release2005-05-05
CE Approval Date2004-08-13
Registered USA Implants110099
Estimated Active USA Implants23745
Normal Battery Depletions15179
US Market Release2005-05-05
CE Approval Date2004-08-13
Estimated WW Distribution142040
Normal Battery Depletions15744
Information

Malfunctions (USA)

Therapy Function Not Compromised 14942
Battery 14814
Electrical Component 58
Electrical Interconnect 2
Possible Early Battery Depletion 67
Other 1
Therapy Function Compromised 55
Battery 6
Electrical Component 38
Electrical Interconnect 4
Possible Early Battery Depletion 2
Other 5
Information

Malfunctions (WW)

Therapy Function Not Compromised 17622
Battery 17417
Electrical Component 112
Electrical Interconnect 4
Possible Early Battery Depletion 85
Software/Firmware 1
Other 3
Therapy Function Compromised 76
Battery 10
Electrical Component 51
Electrical Interconnect 5
Possible Early Battery Depletion 5
Other 5
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