4574 CapSure Sense
Pacing
4574 CapSure Sense
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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    
% Survival 99.1 99.1 99.1 98.9 98.6 98.6 98.6 98.6    
#   973 732 593 447 306 219 125 63    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1230
Cumulative Months of Follow-Up 48995
Number of Leads Active in Study 607
Information 11

Qualifying Complications

Conductor Fracture 2
Failure to Capture 2
Impedance Out of Range 0
Lead Dislodgement 7
Other 0
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 1
Conductor Fracture 1
Extra Cardiac Stimulation 1
Failure to Capture 75
Failure to Sense 31
Impedance Out of Range 3
Lead Dislodgement 179
Oversensing 5
Unspecified Clinical Failure 4
Information

Distribution Data

US Market Release2002-06-23
CE Approval Date2002-02-01
Registered USA Implants95419
Estimated Active USA Implants61724
US Market Release2002-06-23
CE Approval Date2002-02-01
Estimated WW Distribution695291
Information

USA Returned Product Analysis

Conductor Fracture 11
Insulation Breach 16
Crimp/Weld/Bond 0
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 14
Insulation Breach 17
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
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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 April 10, 2020

www.medtronic.com/productperformance 751050