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 97.6 97.6 97.6 97.6 96.9 96.9 96.9 95.7 95.7 95.7
#   229 196 164 149 121 106 83 74 62 54

Product Surveillance Registry Results

Number of Leads Enrolled in Study 342
Cumulative Months of Follow-Up 17469
Number of Leads Active in Study 60
Information 7

Qualifying Complications

Failure to Capture 4
Failure to Sense 1
Lead Dislodgement 2
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 36
Oversensing 2
Unspecified Clinical Failure 2
Information

Distribution Data

US Market Release1998-10-05
CE Approval Date1998-04-15
Registered USA Implants89244
Estimated Active USA Implants34877
US Market Release1998-10-05
CE Approval Date1998-04-15
Estimated WW Distribution202048
Information

USA Returned Product Analysis

Conductor Fracture 8
Insulation Breach 26
Crimp/Weld/Bond 0
Other 1
Information

WW Returned Product Analysis

Conductor Fracture 10
Insulation Breach 26
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 August 3, 2016

www.medtronic.com/productperformance 451050