5076 CapSureFix Novus
Pacing
5076 CapSureFix Novus
VENTRICULAR PLACEMENT
Information

Device Survival Probability

5076_VEN_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                    
% Survival 99.5 99.3 99.1 98.8 98.8 98.4 98.1 97.5 96.7 96.7 96.7                    
#   1129 864 712 568 485 412 341 264 172 115 67                    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2037
Cumulative Months of Follow-Up 70879
Number of Leads Active in Study 656
Information 20

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 4
Failure to Capture 7
Failure to Sense 1
Impedance Out of Range 4
Lead Dislodgement 2
Other 1
ATRIAL PLACEMENT
Information

Device Survival Probability

5076_ATR_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 at 138.0 mo                  
% Survival 99.6 99.6 99.4 99.0 98.8 98.6 98.6 98.5 98.5 98.1 98.1 98.1                  
#   2351 1861 1592 1324 1119 951 800 599 388 227 120 85                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 4208
Cumulative Months of Follow-Up 155504
Number of Leads Active in Study 1801
Information 28

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 3
Extra Cardiac Stimulation 2
Failure to Capture 6
Failure to Sense 2
Impedance Out of Range 4
Insulation (not further defined) 1
Lead Dislodgement 6
Oversensing 1
Other 2
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 227
Conductor Fracture 15
Extra Cardiac Stimulation 18
Failure to Capture 278
Failure to Sense 45
Impedance Out of Range 18
Insulation Breach 8
Lead Dislodgement 681
Oversensing 42
Unspecified Clinical Failure 31
Information

Distribution Data

US Market Release2000-08-31
CE Approval Date1999-08-12
Registered USA Implants1646542
Estimated Active USA Implants1044561
US Market Release2000-08-31
CE Approval Date1999-08-12
Estimated WW Distribution3012168
Information

USA Returned Product Analysis

Conductor Fracture 535
Insulation Breach 542
Crimp/Weld/Bond 0
Other 193
Information

WW Returned Product Analysis

Conductor Fracture 600
Insulation Breach 591
Crimp/Weld/Bond 0
Other 287
Information

Product Characteristics

Lead Type Pacing
Type and/or Fixation Active Screw-in
Lead Function Pacing/Sensing
Lead Placement Transvenous
Lead Tip Location Atrium or Right Ventricle
Pace/Sense Polarity Bipolar
More
Serial Number Prefix PJN
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