8042 InSync III
Cardiac Resynchronization Therapy - Pacing (CRT-Pacing)
8042 InSync III
Information

Device Survival Probability

8042_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 125.0 mo                    
% Excluding Normal Battery Depletion 100.0 100.0 100.0 99.9 99.9 99.9 99.7 99.4 99.0 98.7 98.6                    
% Including Normal Battery Depletion 99.3 99.0 98.0 95.9 92.1 85.2 73.4 55.5 37.5 24.0 17.2                    
#   30360 26002 22334 19088 15926 12180 8666 5587 3073 730 156                    
  • 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

Information

Product Characteristics

Generator Type CRT-Pacing
NBD Code DDDR
Max. Delivered Energy N/A
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Connector Style CRT-P Style
Serial Number Prefix PKF
Mass 26 g
Volume 16 cc
Waveform N/A
X-Ray ID PKF
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CRT-P Style
Information

Estimated Longevity

Amplitude Setting 500 Lead Ω 1000 Lead Ω
Low 2.5 V (A, RV) 8.3 9.9
Nominal 3.5 V (A, RV) 5.9 7.8
High 5.0 V (A, RV) 4.1 6.0
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 %; Left Ventricle Pulse Width 0.4 ms; Left Ventricle Pulse Amplitude same as A, RV; Left Ventricle Percent Paced 100 %; Left Ventricle Lead Impedance same as A, RV; Atrial Fib Percent of Time 0 %; Hide this content

Information

Distribution Data

US Market Release2003-02-25
CE Approval Date2001-02-07
Registered USA Implants39395
Estimated Active USA Implants4671
Normal Battery Depletions5089
US Market Release2003-02-25
CE Approval Date2001-02-07
Estimated WW Distribution96029
Normal Battery Depletions5490
Information

Malfunctions (USA)

Therapy Function Not Compromised 65
Battery 53
Electrical Component 2
Electrical Interconnect 3
Possible Early Battery Depletion 2
Other 5
Therapy Function Compromised 47
Battery 35
Electrical Interconnect 12
Information

Malfunctions (WW)

Therapy Function Not Compromised 132
Battery 112
Electrical Component 8
Electrical Interconnect 5
Possible Early Battery Depletion 2
Other 5
Therapy Function Compromised 81
Battery 49
Electrical Component 3
Electrical Interconnect 29
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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