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 at 198.0 mo        
% Survival 99.5 99.3 99.2 99.1 98.9 98.5 98.4 97.8 97.3 97.3 97.0 97.0 96.5 95.1 95.1 95.1 95.1        
#   2086 1662 1295 1029 876 745 621 474 387 341 272 215 161 133 102 72 60        

Product Surveillance Registry Results

Number of Leads Enrolled in Study 3230
Cumulative Months of Follow-Up 141203
Number of Leads Active in Study 914
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 18 yr      
% Survival 99.6 99.4 99.3 99.1 98.8 98.7 98.4 98.3 98.3 98.2 98.1 97.8 97.7 97.3 97.0 97.0 97.0 97.0      
#   7143 5928 4940 4123 3314 2617 2176 1699 1358 1114 897 705 560 425 290 186 117 60      

Product Surveillance Registry Results

Number of Leads Enrolled in Study 10619
Cumulative Months of Follow-Up 497965
Number of Leads Active in Study 4416
Information 95

Qualifying Complications

Cardiac Perforation 2
Conductor Fracture 11
Extra Cardiac Stimulation 3
Failure to Capture 15
Failure to Sense 9
Impedance Out of Range 7
Insulation (not further defined) 3
Lead Dislodgement 34
Oversensing 5
Other 6
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 1367
Conductor Fracture 27
Extra Cardiac Stimulation 100
Failure to Capture 1795
Failure to Sense 795
Impedance Out of Range 266
Insulation Breach 11
Lead Dislodgement 4365
Oversensing 595
Unspecified Clinical Failure 26
Information

Distribution Data

US Market Release2000-08-31
CE Approval Date1999-08-12
Registered USA Implants2968831
Estimated Active USA Implants1581352
US Market Release2000-08-31
CE Approval Date1999-08-12
Estimated WW Distribution7278066
Information

USA Returned Product Analysis

Conductor Fracture 1273
Insulation Breach 1375
Crimp/Weld/Bond 1
Other 190
Information

WW Returned Product Analysis

Conductor Fracture 1450
Insulation Breach 1502
Crimp/Weld/Bond 1
Other 236
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 December 16, 2021

www.medtronic.com/productperformance 851050