5592 CapSure SP Novus
Pacing
5592 CapSure SP Novus
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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 11 yr 12 yr                  
% Survival 99.6 99.2 99.2 98.9 98.9 98.9 98.9 98.9 98.9 98.9 98.9 98.9                  
#   531 435 347 291 233 180 148 130 109 92 78 53                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 706
Cumulative Months of Follow-Up 35785
Number of Leads Active in Study 49
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 3
Lead Dislodgement 41
Oversensing 1
Unspecified Clinical Failure 1
Information

Distribution Data

US Market Release1998-06-03
CE Approval Date1997-09-25
Registered USA Implants37003
Estimated Active USA Implants17341
US Market Release1998-06-03
CE Approval Date1997-09-25
Estimated WW Distribution127565
Information

USA Returned Product Analysis

Conductor Fracture 5
Insulation Breach 4
Crimp/Weld/Bond 0
Other 1
Information

WW Returned Product Analysis

Conductor Fracture 7
Insulation Breach 4
Crimp/Weld/Bond 0
Other 1
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, 2016

www.medtronic.com/productperformance 451050