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 124.0 mo                    
% Excluding Normal Battery Depletion 99.9 99.9 99.7 98.0 93.6 87.0 81.6 78.2 76.2 75.8 75.8                    
% Including Normal Battery Depletion 99.6 99.5 99.0 96.6 90.2 78.1 62.6 45.6 29.8 12.9 4.6                    
#   94882 88574 82551 75550 65578 51539 37123 23752 12237 2854 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.
Information

Customer Communications For This Model

  • There are no communications 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

Distribution Data

US Market Release2005-05-05
CE Approval Date2004-08-13
Registered USA Implants109806
Estimated Active USA Implants18606
Normal Battery Depletions16738
US Market Release2005-05-05
CE Approval Date2004-08-13
Estimated WW Distribution142032
Normal Battery Depletions17341
Information

Malfunctions (USA)

Therapy Function Not Compromised 15006
Battery 14875
Electrical Component 59
Electrical Interconnect 2
Possible Early Battery Depletion 69
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 17774
Battery 17564
Electrical Component 115
Electrical Interconnect 4
Possible Early Battery Depletion 87
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

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

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