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 17 yr at 210.0 mo      
% Survival 99.6 99.4 99.3 99.1 99.0 98.6 98.5 98.2 97.8 97.8 97.5 97.5 97.0 95.8 95.8 95.8 95.8 95.8      
#   2197 1837 1507 1173 954 798 668 562 470 381 312 248 178 145 125 104 72 59      

Product Surveillance Registry Results

Number of Leads Enrolled in Study 3355
Cumulative Months of Follow-Up 156992
Number of Leads Active in Study 799
Information 32

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 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 19 yr at 234.0 mo  
% Survival 99.6 99.4 99.3 99.1 98.8 98.6 98.4 98.3 98.3 98.2 98.1 97.9 97.6 97.3 97.1 97.1 96.7 96.7 96.7 96.7  
#   7992 6675 5634 4679 3944 3219 2531 2055 1681 1293 1045 833 632 501 395 295 193 123 70 53  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 12432
Cumulative Months of Follow-Up 578296
Number of Leads Active in Study 5235
Information 108

Qualifying Complications

Cardiac Perforation 2
Conductor Fracture 13
Extra Cardiac Stimulation 3
Failure to Capture 17
Failure to Sense 9
Impedance Out of Range 11
Insulation (not further defined) 3
Lead Dislodgement 39
Oversensing 3
Other 8
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 1544
Conductor Fracture 31
Extra Cardiac Stimulation 110
Failure to Capture 2245
Failure to Sense 1124
Impedance Out of Range 367
Insulation Breach 15
Lead Dislodgement 4925
Oversensing 724
Unspecified Clinical Failure 26
Information

Distribution Data

US Market Release2000-08-31
CE Approval Date1999-08-12
Registered USA Implants3204116
Estimated Active USA Implants1770880
US Market Release2000-08-31
CE Approval Date1999-08-12
Estimated WW Distribution8097571
Information

USA Returned Product Analysis

Conductor Fracture 1415
Insulation Breach 1524
Crimp/Weld/Bond 3
Other 199
Information

WW Returned Product Analysis

Conductor Fracture 1610
Insulation Breach 1660
Crimp/Weld/Bond 3
Other 243
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 May 10, 2023

www.medtronic.com/productperformance 926050