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 at 90.0 mo    
% Survival 99.2 99.2 99.2 99.0 98.7 98.7 98.7 98.7    
#   931 706 564 414 286 193 102 61    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1212
Cumulative Months of Follow-Up 46028
Number of Leads Active in Study 630
Information 10

Qualifying Complications

Conductor Fracture 2
Failure to Capture 1
Impedance Out of Range 0
Lead Dislodgement 7
Other 0
Information

US Acute Lead Observations

Cardiac Perforation 1
Conductor Fracture 1
Extra Cardiac Stimulation 1
Failure to Capture 67
Failure to Sense 28
Impedance Out of Range 3
Lead Dislodgement 165
Oversensing 5
Unspecified Clinical Failure 4
Information

Distribution Data

US Market Release2002-06-23
CE Approval Date2002-02-01
Registered USA Implants92847
Estimated Active USA Implants60592
US Market Release2002-06-23
CE Approval Date2002-02-01
Estimated WW Distribution675684
Information

USA Returned Product Analysis

Conductor Fracture 10
Insulation Breach 15
Crimp/Weld/Bond 0
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 13
Insulation Breach 16
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 November 8, 2019

www.medtronic.com/productperformance 726050