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 12 yr                  
% Survival 99.5 99.3 99.2 98.9 98.9 98.3 98.1 97.5 96.8 96.8 96.2 96.2                  
#   1570 1146 811 635 515 419 352 284 215 171 107 69                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2264
Cumulative Months of Follow-Up 86983
Number of Leads Active in Study 705
Information 24

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 4
Failure to Capture 9
Failure to Sense 1
Impedance Out of Range 4
Lead Dislodgement 3
Oversensing 1
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 12 yr at 150.0 mo                
% Survival 99.6 99.6 99.4 99.1 98.9 98.8 98.8 98.7 98.7 98.5 98.5 98.1 98.1                
#   4251 3232 2318 1817 1402 1050 853 689 499 330 191 109 70                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 6204
Cumulative Months of Follow-Up 231942
Number of Leads Active in Study 3233
Information 37

Qualifying Complications

Cardiac Perforation 2
Conductor Fracture 7
Extra Cardiac Stimulation 2
Failure to Capture 7
Failure to Sense 2
Impedance Out of Range 4
Insulation (not further defined) 1
Lead Dislodgement 9
Oversensing 1
Other 2
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 459
Conductor Fracture 17
Extra Cardiac Stimulation 34
Failure to Capture 509
Failure to Sense 102
Impedance Out of Range 35
Insulation Breach 8
Lead Dislodgement 1388
Oversensing 93
Unspecified Clinical Failure 31
Information

Distribution Data

US Market Release2000-08-31
CE Approval Date1999-08-12
Registered USA Implants1967990
Estimated Active USA Implants1211004
US Market Release2000-08-31
CE Approval Date1999-08-12
Estimated WW Distribution4188168
Information

USA Returned Product Analysis

Conductor Fracture 664
Insulation Breach 664
Crimp/Weld/Bond 0
Other 204
Information

WW Returned Product Analysis

Conductor Fracture 750
Insulation Breach 722
Crimp/Weld/Bond 0
Other 303
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 April 14, 2016

www.medtronic.com/productperformance 426050