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 15 yr 16 yr          
% Survival 99.5 99.3 99.2 99.0 98.8 98.5 98.3 97.7 97.2 97.2 96.8 96.8 96.3 94.8 94.8 94.8          
#   2011 1564 1234 1000 854 725 574 431 371 323 260 206 156 122 92 59          

Product Surveillance Registry Results

Number of Leads Enrolled in Study 3164
Cumulative Months of Follow-Up 134658
Number of Leads Active in Study 921
Information 33

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 6
Failure to Capture 12
Failure to Sense 1
Impedance Out of Range 5
Lead Dislodgement 5
Oversensing 1
Other 2
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 16 yr 17 yr at 210.0 mo      
% Survival 99.6 99.5 99.4 99.1 98.8 98.6 98.4 98.2 98.2 98.1 98.0 97.7 97.6 97.1 97.1 97.1 97.1 97.1      
#   6821 5631 4724 3860 3067 2474 2028 1558 1289 1052 842 671 524 376 245 153 93 65      

Product Surveillance Registry Results

Number of Leads Enrolled in Study 10191
Cumulative Months of Follow-Up 469651
Number of Leads Active in Study 4323
Information 91

Qualifying Complications

Cardiac Perforation 2
Conductor Fracture 11
Extra Cardiac Stimulation 3
Failure to Capture 14
Failure to Sense 7
Impedance Out of Range 7
Insulation (not further defined) 3
Lead Dislodgement 33
Oversensing 5
Other 6
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 1343
Conductor Fracture 26
Extra Cardiac Stimulation 99
Failure to Capture 1753
Failure to Sense 771
Impedance Out of Range 256
Insulation Breach 11
Lead Dislodgement 4308
Oversensing 580
Unspecified Clinical Failure 26
Information

Distribution Data

US Market Release2000-08-31
CE Approval Date1999-08-12
Registered USA Implants2942052
Estimated Active USA Implants1559626
US Market Release2000-08-31
CE Approval Date1999-08-12
Estimated WW Distribution7191386
Information

USA Returned Product Analysis

Conductor Fracture 1259
Insulation Breach 1355
Crimp/Weld/Bond 1
Other 189
Information

WW Returned Product Analysis

Conductor Fracture 1434
Insulation Breach 1480
Crimp/Weld/Bond 1
Other 235
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 October 11, 2021

www.medtronic.com/productperformance 826050