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 81.8 78.1 75.8 75.3 75.2                    
% Including Normal Battery Depletion 99.7 99.6 99.1 96.7 90.3 78.3 63.1 46.3 29.9 11.1 3.2                    
#   95567 89233 83193 76177 66162 52126 37527 21702 9783 1839 380                    
  • 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

Distribution Data

US Market Release2005-05-05
CE Approval Date2004-08-13
Registered USA Implants110093
Estimated Active USA Implants22263
Normal Battery Depletions16154
US Market Release2005-05-05
CE Approval Date2004-08-13
Estimated WW Distribution142034
Normal Battery Depletions16723
Information

Malfunctions (USA)

Therapy Function Not Compromised 14971
Battery 14843
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 17674
Battery 17469
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

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 January 31, 2018

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