8040 InSync
Cardiac Resynchronization Therapy - Pacing (CRT-Pacing)
8040 InSync
Information

Device Survival Probability

8040_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 11 yr at 138.0 mo                  
% Excluding Normal Battery Depletion 100.0 100.0 99.9 99.8 99.7 99.6 99.6 99.6 99.5 99.4 99.3 99.3                  
% Including Normal Battery Depletion 99.5 98.9 96.4 92.7 86.5 78.9 67.6 53.3 40.2 28.5 16.3 11.8                  
#   12231 10056 8027 6248 4848 3666 2618 1706 1080 636 284 161                  
  • 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 CRT-Pacing
NBD Code DDDR
Max. Delivered Energy N/A
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Connector Style CRT-P Style
Serial Number Prefix PIN
Mass 32 g
Volume 14.4 cc
Waveform N/A
X-Ray ID PIN
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CRT-P Style
Information

Estimated Longevity

Amplitude Setting 500 Lead Ω 1000 Lead Ω
Low 2.5 V (A, RV) 11.9 13.7
Nominal 3.5 V (A, RV) 8.9 11.4
High 5.0 V (A, RV) 6.6 9.1
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 %; 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 Release2001-08-28
CE Approval Date
Registered USA Implants15332
Estimated Active USA Implants1184
Normal Battery Depletions1485
US Market Release2001-08-28
CE Approval Date
Estimated WW Distribution20115
Normal Battery Depletions1522
Information

Malfunctions (USA)

Therapy Function Not Compromised 24
Electrical Component 4
Electrical Interconnect 16
Possible Early Battery Depletion 3
Other 1
Therapy Function Compromised 10
Electrical Interconnect 10
Information

Malfunctions (WW)

Therapy Function Not Compromised 24
Electrical Component 4
Electrical Interconnect 16
Possible Early Battery Depletion 3
Other 1
Therapy Function Compromised 11
Electrical Interconnect 11
Information

Elective Replacement (ERI)

Telemetry indication. Rate and Mode change to 65 ppm and VVI (VOO/65 with magnet).

Data as of August 3, 2014

www.medtronic.com/productperformance 326050