4592 CapSure SP Novus
Pacing
4592 CapSure SP Novus
ALL
Information

Device Survival Probability

4592_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
% Survival 97.7 97.7 97.7 97.7 97.0 97.0 97.0 96.0 96.0 96.0
#   246 220 195 180 148 121 95 81 66 50

Product Surveillance Registry Results

Number of Leads Enrolled in Study 356
Cumulative Months of Follow-Up 20061
Number of Leads Active in Study 47
Information 8

Qualifying Complications

Failure to Capture 5
Failure to Sense 1
Impedance Out of Range 0
Lead Dislodgement 2
Other 0
Information

US Acute Lead Observations

Failure to Capture 10
Failure to Sense 2
Insulation Breach 1
Lead Dislodgement 37
Oversensing 2
Unspecified Clinical Failure 2
Information

Distribution Data

US Market Release1998-10-05
CE Approval Date1998-04-15
Registered USA Implants88217
Estimated Active USA Implants31822
US Market Release1998-10-05
CE Approval Date1998-04-15
Estimated WW Distribution204022
Information

USA Returned Product Analysis

Conductor Fracture 9
Insulation Breach 30
Crimp/Weld/Bond 0
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 12
Insulation Breach 32
Crimp/Weld/Bond 0
Other 2
Information

Product Characteristics

Lead Type Pacing
Type and/or Fixation J-shape, tines
Lead Function Pacing/Sensing
Lead Placement Transvenous
Lead Tip Location Atrium
Pace/Sense Polarity Bipolar
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Serial Number Prefix LER
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