4092 CapSure SP Novus
Pacing
4092 CapSure SP Novus
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Information

Device Survival Probability

4092_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 98.8 98.7 98.5 98.1 97.8 97.4 97.4 97.4 97.4 97.4 97.4                    
#   950 847 754 645 523 398 325 264 215 131 68                    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1197
Cumulative Months of Follow-Up 68706
Number of Leads Active in Study 37
Information 21

Qualifying Complications

Conductor Fracture 3
Extra Cardiac Stimulation 1
Failure to Capture 12
Impedance Out of Range 1
Lead Dislodgement 4
Other 0
Information

US Acute Lead Observations

Cardiac Perforation 4
Conductor Fracture 4
Extra Cardiac Stimulation 1
Failure to Capture 35
Impedance Out of Range 2
Insulation Breach 1
Lead Dislodgement 35
Oversensing 1
Unspecified Clinical Failure 1
Information

Distribution Data

US Market Release1998-09-17
CE Approval Date1998-04-15
Registered USA Implants185510
Estimated Active USA Implants63403
US Market Release1998-09-17
CE Approval Date1998-04-15
Estimated WW Distribution563737
Information

USA Returned Product Analysis

Conductor Fracture 18
Insulation Breach 87
Crimp/Weld/Bond 0
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 18
Insulation Breach 94
Crimp/Weld/Bond 0
Other 2
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
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Serial Number Prefix LEP
Lead Body Diameter 5.3 FR
Insulation Polyurethane (outer) Silicone (inner)
Pace/Sense Connector Style IS-1 BI
High Voltage Connector n/a
Steroid Yes
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Data as of November 8, 2019

www.medtronic.com/productperformance 726050