5038 CapSure VDD-2
VDD Single Pass Pacing
5038 CapSure VDD-2
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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 99.3 99.3 97.9 97.0 97.0 94.1      
#   288 218 160 132 104 78 56      

Product Surveillance Registry Results

Number of Leads Enrolled in Study 568
Cumulative Months of Follow-Up 15833
Number of Leads Active in Study 3
Information 8

Qualifying Complications

Conductor Fracture 3
Failure to Capture 2
Failure to Sense 3
Impedance Out of Range 0
Other 0
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Extra Cardiac Stimulation 1
Failure to Capture 3
Failure to Sense 2
Lead Dislodgement 7
Oversensing 1
Information

Distribution Data

US Market Release1998-09-10
CE Approval Date1997-04-15
Registered USA Implants10367
Estimated Active USA Implants3523
US Market Release1998-09-10
CE Approval Date1997-04-15
Estimated WW Distribution169095
Information

USA Returned Product Analysis

Conductor Fracture 8
Insulation Breach 2
Crimp/Weld/Bond 0
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 20
Insulation Breach 13
Crimp/Weld/Bond 0
Other 1
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 October 29, 2020

www.medtronic.com/productperformance 776050