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 at 150.0 mo                
% Survival 99.5 99.3 99.1 98.9 98.9 98.6 98.6 98.6 98.6 98.6 97.8 97.8 97.8                
#   828 662 525 428 338 260 210 163 136 118 95 70 61                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1213
Cumulative Months of Follow-Up 53286
Number of Leads Active in Study 34
Information 10

Qualifying Complications

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

US Acute Lead Observations

Cardiac Perforation 7
Conductor Fracture 2
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 Implants140126
Estimated Active USA Implants50270
US Market Release1998-06-03
CE Approval Date1997-09-25
Estimated WW Distribution464048
Information

USA Returned Product Analysis

Conductor Fracture 23
Insulation Breach 64
Crimp/Weld/Bond 0
Other 1
Information

WW Returned Product Analysis

Conductor Fracture 24
Insulation Breach 68
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 November 8, 2019

www.medtronic.com/productperformance 726050