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 at 118.0 mo
% Excluding Normal Battery Depletion 100.0 99.9 99.7 98.1 93.7 86.8 80.7 76.0 72.8 72.1
% Including Normal Battery Depletion 99.8 99.7 99.2 96.8 90.5 78.9 64.5 48.4 32.3 12.3
#   94875 88629 82665 75690 64836 46764 30264 17125 7431 590
  • 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 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 Implants110094
Estimated Active USA Implants32889
Normal Battery Depletions10111
US Market Release2005-05-05
CE Approval Date2004-08-13
Estimated WW Distribution142052
Normal Battery Depletions10593
Information

Malfunctions (USA)

Therapy Function Not Compromised 14443
Battery 14317
Electrical Component 57
Electrical Interconnect 2
Possible Early Battery Depletion 65
Other 2
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 16866
Battery 16668
Electrical Component 108
Electrical Interconnect 4
Possible Early Battery Depletion 81
Software/Firmware 1
Other 4
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 April 14, 2016

www.medtronic.com/productperformance 426050