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 at 150.0 mo                
% Survival 99.5 99.3 99.2 99.0 99.0 98.4 98.1 97.6 97.0 97.0 96.4 96.4 95.3                
#   1613 1283 902 661 541 434 357 291 230 182 137 85 63                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2301
Cumulative Months of Follow-Up 92556
Number of Leads Active in Study 652
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 13 yr                
% Survival 99.6 99.6 99.4 99.1 99.0 98.8 98.8 98.7 98.7 98.5 98.5 98.2 98.2                
#   4586 3634 2628 1945 1522 1130 868 709 544 372 241 131 65                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 6802
Cumulative Months of Follow-Up 253638
Number of Leads Active in Study 3548
Information 40

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 11
Oversensing 2
Other 2
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 517
Conductor Fracture 19
Extra Cardiac Stimulation 38
Failure to Capture 583
Failure to Sense 136
Impedance Out of Range 41
Insulation Breach 8
Lead Dislodgement 1530
Oversensing 109
Unspecified Clinical Failure 31
Information

Distribution Data

US Market Release2000-08-31
CE Approval Date1999-08-12
Registered USA Implants2034856
Estimated Active USA Implants1267531
US Market Release2000-08-31
CE Approval Date1999-08-12
Estimated WW Distribution4381647
Information

USA Returned Product Analysis

Conductor Fracture 702
Insulation Breach 699
Crimp/Weld/Bond 0
Other 205
Information

WW Returned Product Analysis

Conductor Fracture 794
Insulation Breach 758
Crimp/Weld/Bond 0
Other 308
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, 2016

www.medtronic.com/productperformance 451050