4592 CapSure SP Novus
Pacing
4592 CapSure SP Novus
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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 11 yr 12 yr at 150.0 mo
% Survival 97.7 97.7 97.7 97.7 97.0 97.0 97.0 96.0 96.0 96.0      
#   201 178 162 152 129 121 104 100 88 75 70 65 54

Product Surveillance Registry Results

Number of Leads Enrolled in Study 358
Cumulative Months of Follow-Up 20603
Number of Leads Active in Study 37
Information 9

Qualifying Complications

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

Customer Communications For This Model

  • There are no communications for this model.
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 Implants88230
Estimated Active USA Implants30299
US Market Release1998-10-05
CE Approval Date1998-04-15
Estimated WW Distribution204126
Information

USA Returned Product Analysis

Conductor Fracture 10
Insulation Breach 30
Crimp/Weld/Bond 0
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 13
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 October 29, 2020

www.medtronic.com/productperformance 776050