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 13 yr 14 yr              
% Survival 99.5 99.2 99.2 99.0 98.7 98.3 98.2 97.7 97.2 97.2 96.8 96.8 96.3 95.4              
#   2011 1509 1237 1003 847 639 440 336 260 202 164 129 93 61              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 3054
Cumulative Months of Follow-Up 123039
Number of Leads Active in Study 968
Information 31

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 6
Failure to Capture 12
Failure to Sense 1
Impedance Out of Range 4
Lead Dislodgement 5
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 14 yr 15 yr at 186.0 mo          
% Survival 99.6 99.4 99.3 99.1 98.7 98.6 98.3 98.2 98.2 98.1 97.9 97.6 97.5 97.2 97.2 97.2          
#   7077 5760 4666 3585 2808 2072 1403 1019 733 505 373 290 202 119 66 55          

Product Surveillance Registry Results

Number of Leads Enrolled in Study 9567
Cumulative Months of Follow-Up 417965
Number of Leads Active in Study 4316
Information 83

Qualifying Complications

Cardiac Perforation 2
Conductor Fracture 11
Extra Cardiac Stimulation 3
Failure to Capture 14
Failure to Sense 6
Impedance Out of Range 7
Insulation (not further defined) 2
Lead Dislodgement 29
Oversensing 4
Other 5
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 1137
Conductor Fracture 25
Extra Cardiac Stimulation 86
Failure to Capture 1407
Failure to Sense 562
Impedance Out of Range 149
Insulation Breach 11
Lead Dislodgement 3524
Oversensing 440
Unspecified Clinical Failure 26
Information

Distribution Data

US Market Release2000-08-31
CE Approval Date1999-08-12
Registered USA Implants2697765
Estimated Active USA Implants1788609
US Market Release2000-08-31
CE Approval Date1999-08-12
Estimated WW Distribution6337449
Information

USA Returned Product Analysis

Conductor Fracture 1112
Insulation Breach 1174
Crimp/Weld/Bond 0
Other 180
Information

WW Returned Product Analysis

Conductor Fracture 1258
Insulation Breach 1282
Crimp/Weld/Bond 0
Other 223
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 10, 2020

www.medtronic.com/productperformance 751050