5092 CapSure SP Novus
Pacing
5092 CapSure SP Novus
ALL
Information

Device Survival Probability


5092_SURV
    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr 10 yr at 126 mo                    
% Survival 99.5 99.3 99.1 98.9 98.9 98.5 98.5 98.5 98.5 98.5 97.0                    
#   801 637 501 401 317 244 194 147 105 75 53                    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1187
Cumulative Months of Follow-Up 47405
Number of Leads Active in Study 128
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 1
Extra Cardiac Stimulation 3
Failure to Capture 38
Failure to Sense 6
Insulation Breach 3
Lead Dislodgement 54
Oversensing 1
Unspecified Clinical Failure 9
Information

Distribution Data

US Market Release1998-06-03
CE Approval Date1997-09-25
Registered USA Implants135810
Estimated Active USA Implants61274
US Market Release1998-06-03
CE Approval Date1997-09-25
Estimated WW Distribution367337
Information

USA Returned Product Analysis

Conductor Fracture 12
Insulation Breach 40
Crimp/Weld/Bond 0
Other 3
Information

WW Returned Product Analysis

Conductor Fracture 12
Insulation Breach 43
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
Hide this content

Data as of January 31, 2014

www.medtronic.com/productperformance 301050