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 at 114.0 mo
% Survival 97.5 97.5 97.5 97.5 96.7 96.7 96.7 95.5 95.5 95.5
#   199 171 151 138 111 100 81 71 61 51

Product Surveillance Registry Results

Number of Leads Enrolled in Study 324
Cumulative Months of Follow-Up 15835
Number of Leads Active in Study 56
Information 7

Qualifying Complications

Failure to Capture 4
Failure to Sense 1
Impedance Out of Range 0
Lead Dislodgement 2
Other 0
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Failure to Capture 8
Failure to Sense 2
Insulation Breach 1
Lead Dislodgement 31
Oversensing 2
Unspecified Clinical Failure 2
Information

Distribution Data

US Market Release1998-10-05
CE Approval Date1998-04-15
Registered USA Implants88084
Estimated Active USA Implants39708
US Market Release1998-10-05
CE Approval Date1998-04-15
Estimated WW Distribution186878
Information

USA Returned Product Analysis

Conductor Fracture 7
Insulation Breach 22
Crimp/Weld/Bond 0
Other 1
Information

WW Returned Product Analysis

Conductor Fracture 9
Insulation Breach 22
Crimp/Weld/Bond 0
Other 4
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 February 9, 2015

www.medtronic.com/productperformance 351052