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                    
% Survival 99.5 99.3 99.1 98.9 98.9 98.5 98.5 98.5 98.5 98.5 97.3                    
#   803 637 501 404 319 249 201 150 114 89 58                    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1189
Cumulative Months of Follow-Up 48452
Number of Leads Active in Study 96
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 6
Conductor Fracture 2
Extra Cardiac Stimulation 3
Failure to Capture 42
Failure to Sense 7
Insulation Breach 3
Lead Dislodgement 58
Oversensing 1
Unspecified Clinical Failure 9
Information

Distribution Data

US Market Release1998-06-03
CE Approval Date1997-09-25
Registered USA Implants137275
Estimated Active USA Implants62038
US Market Release1998-06-03
CE Approval Date1997-09-25
Estimated WW Distribution373659
Information

USA Returned Product Analysis

Conductor Fracture 14
Insulation Breach 41
Crimp/Weld/Bond 0
Other 3
Information

WW Returned Product Analysis

Conductor Fracture 14
Insulation Breach 44
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 August 3, 2014

www.medtronic.com/productperformance 326050