AT501 AT500
Implantable Pulse Generator (IPG)
AT501 AT500
Information

Device Survival Probability


AT501_7253_SURV
    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr at 83 mo      
% Excluding Normal Battery Depletion 100.0 100.0 100.0 99.9 99.9 99.9 99.9      
% Including Normal Battery Depletion 99.9 99.8 99.4 97.5 85.5 55.2 1.4      
#   10724 9962 9151 8287 6279 2878 184      
  • 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

Product Characteristics

Generator Type IPG
NBD Code DDDRP
Max. Delivered Energy N/A
More
Connector Style IS-1 UNI/BI
Serial Number Prefix IJF
Mass 26 g
Volume 14.1 cc
Waveform N/A
X-Ray ID IJF
Hide this content
IS-1 UNI/BI
Information

Estimated Longevity

Amplitude Setting 500 Lead Ω 1000 Lead Ω
Low 2.5 V (A, RV) 7.7 8.3
Nominal 3.5 V (A, RV) 5.8 7.0
High 5.0 V (A, RV) 3.7 5.2
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 %; Activity ON ; Atrial Fib Percent of Time 0 %; 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 Release2003-03-26
CE Approval Date
Registered USA Implants11144
Estimated Active USA Implants903
Normal Battery Depletions2808
US Market Release2003-03-26
CE Approval Date
Estimated WW Distribution26065
Normal Battery Depletions3328
Information

Malfunctions (USA)

Therapy Function Not Compromised 4
Electrical Component 1
Possible Early Battery Depletion 3
Therapy Function Compromised 5
Electrical Component 3
Electrical Interconnect 1
Possible Early Battery Depletion 1
Information

Malfunctions (WW)

Therapy Function Not Compromised 16
Electrical Component 9
Possible Early Battery Depletion 4
Other 3
Therapy Function Compromised 25
Electrical Component 23
Electrical Interconnect 1
Possible Early Battery Depletion 1
Information

Elective Replacement (ERI)

Telemetry indication. Pacing mode and rate (magnet and non-magnet) as programmed.

Data as of March 12, 2013

www.medtronic.com/productperformance 251050