5076 CapSureFix Novus
Pacing
5076 CapSureFix Novus
VENTRICULAR PLACEMENT
Information

Device Survival Probability

5076_VEN_SURV
Loading...











    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 98.4 98.3 97.8 97.3 97.3 97.0 97.0 96.4 95.6 95.6 95.6          
#   1929 1490 1205 976 836 703 526 421 362 305 251 201 150 115 79 51          

Product Surveillance Registry Results

Number of Leads Enrolled in Study 3108
Cumulative Months of Follow-Up 129553
Number of Leads Active in Study 934
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
Loading...











    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        
% 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 97.3 97.3 97.3 97.3        
#   6521 5407 4548 3605 2869 2366 1872 1489 1239 999 805 644 489 330 206 132 69        

Product Surveillance Registry Results

Number of Leads Enrolled in Study 9874
Cumulative Months of Follow-Up 446886
Number of Leads Active in Study 4321
Information 86

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) 3
Lead Dislodgement 31
Oversensing 4
Other 5
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 1212
Conductor Fracture 25
Extra Cardiac Stimulation 92
Failure to Capture 1513
Failure to Sense 632
Impedance Out of Range 192
Insulation Breach 11
Lead Dislodgement 3752
Oversensing 473
Unspecified Clinical Failure 26
Information

Distribution Data

US Market Release2000-08-31
CE Approval Date1999-08-12
Registered USA Implants2777413
Estimated Active USA Implants1841973
US Market Release2000-08-31
CE Approval Date1999-08-12
Estimated WW Distribution6547727
Information

USA Returned Product Analysis

Conductor Fracture 1146
Insulation Breach 1223
Crimp/Weld/Bond 0
Other 185
Information

WW Returned Product Analysis

Conductor Fracture 1300
Insulation Breach 1335
Crimp/Weld/Bond 0
Other 228
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
Hide this content

Data as of October 29, 2020

www.medtronic.com/productperformance 776050