4574 CapSure Sense
Pacing
4574 CapSure Sense
ALL
Information

Device Survival Probability

4574_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 12 yr at 150.0 mo                
% Survival 99.3 99.3 99.2 98.9 98.6 98.4 98.4 98.4 98.4 98.4 98.4 98.4 98.4                
#   1408 1099 872 687 552 466 392 331 265 188 132 80 63                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1782
Cumulative Months of Follow-Up 88920
Number of Leads Active in Study 561
Information 17

Qualifying Complications

Conductor Fracture 2
Failure to Capture 8
Lead Dislodgement 7
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 6
Conductor Fracture 1
Extra Cardiac Stimulation 1
Failure to Capture 203
Failure to Sense 100
Impedance Out of Range 12
Lead Dislodgement 298
Oversensing 19
Unspecified Clinical Failure 4
Information

Distribution Data

US Market Release2002-06-23
CE Approval Date2002-02-01
Registered USA Implants127590
Estimated Active USA Implants74399
US Market Release2002-06-23
CE Approval Date2002-02-01
Estimated WW Distribution974921
Information

USA Returned Product Analysis

Conductor Fracture 14
Insulation Breach 26
Crimp/Weld/Bond 0
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 20
Insulation Breach 29
Crimp/Weld/Bond 0
Other 2
Information

Product Characteristics

Lead Type Pacing
Type and/or Fixation J-shape, tines
Lead Function Pacing/Sensing
Lead Placement Transvenous
Lead Tip Location Atrium
Pace/Sense Polarity Bipolar
More
Serial Number Prefix BBE
Lead Body Diameter 5.3 FR
Insulation Polyurethane (outer) Silicone (inner)
Pace/Sense Connector Style IS-1 BI
High Voltage Connector n/a
Steroid Yes
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Data as of May 24, 2025

www.medtronic.com/productperformance 1051050