5092 CapSure SP Novus
Pacing
5092 CapSure SP Novus
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Information

Device Survival Probability

5092_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 99.5 99.3 99.1 98.9 98.9 98.5 98.5 98.5 98.5 98.5 97.6 97.6                  
#   821 653 508 410 321 252 205 159 126 103 77 63                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1202
Cumulative Months of Follow-Up 50314
Number of Leads Active in Study 104
Information 10

Qualifying Complications

Extra Cardiac Stimulation 1
Failure to Capture 3
Impedance Out of Range 1
Lead Dislodgement 5
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 7
Conductor Fracture 2
Extra Cardiac Stimulation 3
Failure to Capture 48
Failure to Sense 7
Impedance Out of Range 1
Insulation Breach 3
Lead Dislodgement 65
Oversensing 1
Unspecified Clinical Failure 9
Information

Distribution Data

US Market Release1998-06-03
CE Approval Date1997-09-25
Registered USA Implants139822
Estimated Active USA Implants54890
US Market Release1998-06-03
CE Approval Date1997-09-25
Estimated WW Distribution441478
Information

USA Returned Product Analysis

Conductor Fracture 17
Insulation Breach 45
Crimp/Weld/Bond 0
Other 3
Information

WW Returned Product Analysis

Conductor Fracture 17
Insulation Breach 48
Crimp/Weld/Bond 0
Other 14
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 LET
Lead Body Diameter 6.0 FR
Insulation Silicone
Pace/Sense Connector Style IS-1 BI
High Voltage Connector n/a
Steroid Yes
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Data as of November 2, 2015

www.medtronic.com/productperformance 376051