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 12 yr 13 yr at 162.0 mo              
% Survival 99.5 99.3 99.2 98.9 98.9 98.6 98.6 98.6 98.6 98.6 97.8 97.8 97.8 97.8              
#   814 652 517 421 335 265 218 173 149 133 109 81 56 52              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1216
Cumulative Months of Follow-Up 54564
Number of Leads Active in Study 16
Information 10

Qualifying Complications

Extra Cardiac Stimulation 1
Failure to Capture 3
Impedance Out of Range 1
Lead Dislodgement 5
Other 0
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 7
Conductor Fracture 3
Extra Cardiac Stimulation 3
Failure to Capture 49
Failure to Sense 7
Impedance Out of Range 1
Insulation Breach 3
Lead Dislodgement 72
Oversensing 1
Unspecified Clinical Failure 8
Information

Distribution Data

US Market Release1998-06-03
CE Approval Date1997-09-25
Registered USA Implants141703
Estimated Active USA Implants29378
US Market Release1998-06-03
CE Approval Date1997-09-25
Estimated WW Distribution468888
Information

USA Returned Product Analysis

Conductor Fracture 27
Insulation Breach 72
Crimp/Weld/Bond 0
Other 1
Information

WW Returned Product Analysis

Conductor Fracture 27
Insulation Breach 76
Crimp/Weld/Bond 0
Other 5
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 December 1, 2023

www.medtronic.com/productperformance 951051