5092 CapSure SP Novus
Pacing
5092 CapSure SP Novus
ALL
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 12 yr                  
% 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                  
#   820 651 505 410 321 252 206 159 126 106 81 55                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1204
Cumulative Months of Follow-Up 50481
Number of Leads Active in Study 105
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 68
Oversensing 1
Unspecified Clinical Failure 9
Information

Distribution Data

US Market Release1998-06-03
CE Approval Date1997-09-25
Registered USA Implants140407
Estimated Active USA Implants54348
US Market Release1998-06-03
CE Approval Date1997-09-25
Estimated WW Distribution445974
Information

USA Returned Product Analysis

Conductor Fracture 19
Insulation Breach 45
Crimp/Weld/Bond 0
Other 3
Information

WW Returned Product Analysis

Conductor Fracture 19
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 April 14, 2016

www.medtronic.com/productperformance 426050