4024 CapSure SP
Pacing
4024 CapSure SP
ALL
Information

Device Survival Probability

4024_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr  
% Survival 99.8 99.6 99.6 99.6 99.6 99.6 99.6 99.6 98.0  
#   430 322 251 183 146 118 94 70 60  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1220
Cumulative Months of Follow-Up 25107
Number of Leads Active in Study 10
Information 4

Qualifying Complications

Failure to Capture 3
Insulation (not further defined) 1
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 13
Conductor Fracture 10
Extra Cardiac Stimulation 2
Failure to Capture 103
Failure to Sense 16
Impedance Out of Range 8
Insulation Breach 1
Lead Dislodgement 49
Oversensing 2
Unspecified Clinical Failure 20
Information

Distribution Data

US Market Release1991-10-01
CE Approval Date
Registered USA Implants218562
Estimated Active USA Implants39584
US Market Release1991-10-01
CE Approval Date
Estimated WW Distribution277574
Information

USA Returned Product Analysis

Conductor Fracture 28
Insulation Breach 192
Crimp/Weld/Bond 0
Other 12
Information

WW Returned Product Analysis

Conductor Fracture 32
Insulation Breach 214
Crimp/Weld/Bond 0
Other 45
Information

Product Characteristics

Lead Type Pacing
Type and/or Fixation Tines
Lead Function Pacing/Sensing
Lead Placement Transvenous
Lead Tip Location Right Ventricle
Pace/Sense Polarity Bipolar
More
Serial Number Prefix LAJ
Lead Body Diameter 5.7 FR
Insulation Polyurethane
Pace/Sense Connector Style IS-1 BI
High Voltage Connector n/a
Steroid Yes
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Data as of January 31, 2014

www.medtronic.com/productperformance 301050