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 99.4 99.3 99.1 98.9 98.9 98.4 98.2 97.6 96.9 96.9 96.2 96.2                  
#   1455 1026 789 622 504 417 349 279 205 158 95 57                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2208
Cumulative Months of Follow-Up 82360
Number of Leads Active in Study 712
Information 23

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 4
Failure to Capture 9
Failure to Sense 1
Impedance Out of Range 4
Lead Dislodgement 3
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                  
% Survival 99.7 99.6 99.5 99.1 98.9 98.8 98.8 98.7 98.7 98.5 98.5 98.5                  
#   3802 2745 2086 1654 1270 991 838 668 452 297 163 84                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 5747
Cumulative Months of Follow-Up 208187
Number of Leads Active in Study 2992
Information 32

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 7
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 372
Conductor Fracture 17
Extra Cardiac Stimulation 28
Failure to Capture 434
Failure to Sense 80
Impedance Out of Range 32
Insulation Breach 8
Lead Dislodgement 1153
Oversensing 75
Unspecified Clinical Failure 31
Information

Distribution Data

US Market Release2000-08-31
CE Approval Date1999-08-12
Registered USA Implants1871477
Estimated Active USA Implants1134484
US Market Release2000-08-31
CE Approval Date1999-08-12
Estimated WW Distribution3964464
Information

USA Returned Product Analysis

Conductor Fracture 625
Insulation Breach 638
Crimp/Weld/Bond 0
Other 200
Information

WW Returned Product Analysis

Conductor Fracture 710
Insulation Breach 694
Crimp/Weld/Bond 0
Other 299
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 November 2, 2015

www.medtronic.com/productperformance 376051