5038 CapSure VDD-2
VDD Single Pass Pacing
5038 CapSure VDD-2
ALL
Information

Device Survival Probability

5038_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr      
% Survival 99.7 99.7 99.7 98.2 97.4 97.4 94.4      
#   291 219 161 132 105 77 55      

Product Surveillance Registry Results

Number of Leads Enrolled in Study 567
Cumulative Months of Follow-Up 15654
Number of Leads Active in Study 4
Information 7

Qualifying Complications

Conductor Fracture 3
Failure to Capture 1
Failure to Sense 3
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Extra Cardiac Stimulation 1
Failure to Capture 1
Failure to Sense 2
Lead Dislodgement 4
Information

Distribution Data

US Market Release1998-09-10
CE Approval Date1997-04-15
Registered USA Implants9383
Estimated Active USA Implants3167
US Market Release1998-09-10
CE Approval Date1997-04-15
Estimated WW Distribution146351
Information

USA Returned Product Analysis

Conductor Fracture 5
Insulation Breach 1
Crimp/Weld/Bond 0
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 17
Insulation Breach 10
Crimp/Weld/Bond 0
Other 11
Information

Product Characteristics

Lead Type VDD Single Pass
Type and/or Fixation Tines
Lead Function Pacing/Sensing
Lead Placement Transvenous
Lead Tip Location Right Ventricle
Pace/Sense Polarity Quadripolar
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Serial Number Prefix LEG, LEE, LEF
Lead Body Diameter 8.1 FR
Insulation Silicone
Pace/Sense Connector Style Two IS-1 Bi
High Voltage Connector n/a
Steroid Yes
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Data as of April 14, 2016

www.medtronic.com/productperformance 426050