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 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                  
#   531 441 356 291 233 181 150 131 109 94 79 54                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 707
Cumulative Months of Follow-Up 36123
Number of Leads Active in Study 47
Information 5

Qualifying Complications

Failure to Capture 3
Impedance Out of Range 0
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 43
Oversensing 1
Unspecified Clinical Failure 1
Information

Distribution Data

US Market Release1998-06-03
CE Approval Date1997-09-25
Registered USA Implants37160
Estimated Active USA Implants17268
US Market Release1998-06-03
CE Approval Date1997-09-25
Estimated WW Distribution128404
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
More
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 February 3, 2017

www.medtronic.com/productperformance 476050