5592 CapSure SP Novus
Pacing
5592 CapSure SP Novus
ALL
Information

Device Survival Probability

5592_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 99.6 99.2 99.2 98.9 98.9 98.9 98.9 98.9 98.9 98.9
#   510 420 335 279 224 166 134 106 75 55

Product Surveillance Registry Results

Number of Leads Enrolled in Study 693
Cumulative Months of Follow-Up 31746
Number of Leads Active in Study 116
Information 5

Qualifying Complications

Failure to Capture 3
Lead Dislodgement 2
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 1
Failure to Capture 4
Failure to Sense 2
Lead Dislodgement 32
Oversensing 1
Unspecified Clinical Failure 1
Information

Distribution Data

US Market Release1998-06-03
CE Approval Date1997-09-25
Registered USA Implants35914
Estimated Active USA Implants19344
US Market Release1998-06-03
CE Approval Date1997-09-25
Estimated WW Distribution107381
Information

USA Returned Product Analysis

Conductor Fracture 4
Insulation Breach 4
Crimp/Weld/Bond 0
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 5
Insulation Breach 4
Crimp/Weld/Bond 0
Other 0
Information

Product Characteristics

Lead Type Pacing
Type and/or Fixation Tines
Lead Function Pacing/Sensing
Lead Placement Transvenous
Lead Tip Location Atrium - J
Pace/Sense Polarity Bipolar
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Serial Number Prefix LEU
Lead Body Diameter 6.0 FR
Insulation Silicone
Pace/Sense Connector Style IS-1 BI
High Voltage Connector n/a
Steroid Yes
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Data as of August 3, 2014

www.medtronic.com/productperformance 326050