5592 CapSure SP Novus
Pacing
5592 CapSure SP Novus
ALL
Information

Device Survival Probability

5592_SURV
Loading...











    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr at 114.0 mo
% Survival 99.6 99.2 99.2 98.9 98.9 98.9 98.9 98.9 98.9 98.9
#   507 418 333 277 223 162 129 104 70 52

Product Surveillance Registry Results

Number of Leads Enrolled in Study 687
Cumulative Months of Follow-Up 31066
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 30
Oversensing 1
Unspecified Clinical Failure 1
Information

Distribution Data

US Market Release1998-06-03
CE Approval Date1997-09-25
Registered USA Implants35455
Estimated Active USA Implants19100
US Market Release1998-06-03
CE Approval Date1997-09-25
Estimated WW Distribution105698
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
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
Hide this content

Data as of January 31, 2014

www.medtronic.com/productperformance 301050