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 at 150.0 mo                
% 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 98.9                
#   523 432 351 298 248 194 157 141 118 106 94 66 56                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 718
Cumulative Months of Follow-Up 37927
Number of Leads Active in Study 40
Information 5

Qualifying Complications

Failure to Capture 3
Impedance Out of Range 0
Lead Dislodgement 2
Other 0
Information

Customer Communications For This Model

  • There are no communications 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 Implants36938
Estimated Active USA Implants15431
US Market Release1998-06-03
CE Approval Date1997-09-25
Estimated WW Distribution130234
Information

USA Returned Product Analysis

Conductor Fracture 6
Insulation Breach 7
Crimp/Weld/Bond 0
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 8
Insulation Breach 7
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
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 October 29, 2020

www.medtronic.com/productperformance 776050