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 11 yr 12 yr 13 yr                
% Survival 97.7 97.7 97.7 97.7 97.0 97.0 97.0 96.1 96.1 96.1 96.1 96.1 96.1                
#   203 181 166 157 133 125 108 104 97 86 81 75 56                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 366
Cumulative Months of Follow-Up 22549
Number of Leads Active in Study 27
Information 9

Qualifying Complications

Failure to Capture 4
Failure to Sense 1
Impedance Out of Range 0
Lead Dislodgement 3
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 Implants89798
Estimated Active USA Implants19854
US Market Release1998-10-05
CE Approval Date1998-04-15
Estimated WW Distribution203520
Information

USA Returned Product Analysis

Conductor Fracture 17
Insulation Breach 34
Crimp/Weld/Bond 0
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 19
Insulation Breach 36
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
More
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 December 1, 2023

www.medtronic.com/productperformance 951051