4568 CapSureFix
Pacing
4568 CapSureFix
ALL
Information

Device Survival Probability

4568_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 at 126.0 mo                    
% Survival 96.6 96.2 95.0 94.0 93.2 93.2 91.4 91.4 90.4 90.4 90.4                    
#   493 419 329 277 228 173 139 105 84 63 51                    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 671
Cumulative Months of Follow-Up 32103
Number of Leads Active in Study 8
Information 38

Qualifying Complications

Conductor Fracture 1
Failure to Capture 20
Failure to Sense 4
Impedance Out of Range 3
Lead Dislodgement 9
Medical Judgement 1
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 3
Conductor Fracture 1
Failure to Capture 6
Failure to Sense 1
Impedance Out of Range 2
Lead Dislodgement 4
Oversensing 1
Unspecified Clinical Failure 1
Information

Distribution Data

US Market Release1997-01-02
CE Approval Date
Registered USA Implants69452
Estimated Active USA Implants14734
US Market Release1997-01-02
CE Approval Date
Estimated WW Distribution94264
Information

USA Returned Product Analysis

Conductor Fracture 10
Insulation Breach 119
Crimp/Weld/Bond 0
Other 52
Information

WW Returned Product Analysis

Conductor Fracture 10
Insulation Breach 123
Crimp/Weld/Bond 0
Other 130
Information

Product Characteristics

Lead Type Pacing
Type and/or Fixation J-shape, screw in
Lead Function Pacing/Sensing
Lead Placement Transvenous
Lead Tip Location Atrium
Pace/Sense Polarity Bipolar
More
Serial Number Prefix LDD
Lead Body Diameter 7.5 FR
Insulation Polyurethane
Pace/Sense Connector Style IS-1 BI
High Voltage Connector n/a
Steroid Yes
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Data as of July 31, 2017

www.medtronic.com/productperformance 501050