4524 CapSure SP
Pacing
4524 CapSure SP
ALL
Information

Device Survival Probability

4524_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                  
% Survival 99.3 98.6 98.6 98.1 98.1 98.1 98.1 98.1 98.1 98.1 98.1 98.1                  
#   362 274 217 163 131 106 85 74 65 55 53 51                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 916
Cumulative Months of Follow-Up 23020
Number of Leads Active in Study 28
Information 7

Qualifying Complications

Failure to Capture 3
Failure to Sense 2
Impedance Out of Range 1
Lead Dislodgement 1
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 2
Conductor Fracture 2
Failure to Capture 15
Failure to Sense 4
Impedance Out of Range 1
Insulation Breach 2
Lead Dislodgement 23
Unspecified Clinical Failure 12
Information

Distribution Data

US Market Release1991-10-01
CE Approval Date
Registered USA Implants100264
Estimated Active USA Implants22630
US Market Release1991-10-01
CE Approval Date
Estimated WW Distribution125099
Information

USA Returned Product Analysis

Conductor Fracture 1
Insulation Breach 71
Crimp/Weld/Bond 0
Other 3
Information

WW Returned Product Analysis

Conductor Fracture 1
Insulation Breach 72
Crimp/Weld/Bond 0
Other 11
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 LAR
Lead Body Diameter 6.2 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