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 at 138.0 mo                  
% Survival 99.4 99.2 99.1 98.8 98.8 98.3 98.1 97.5 96.8 96.8 95.9 95.9                  
#   1300 913 749 592 491 415 349 274 198 134 81 63                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2133
Cumulative Months of Follow-Up 76607
Number of Leads Active in Study 694
Information 23

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 4
Failure to Capture 9
Failure to Sense 1
Impedance Out of Range 4
Lead Dislodgement 3
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                  
% Survival 99.7 99.6 99.4 99.1 98.8 98.7 98.7 98.6 98.6 98.3 98.3 98.3                  
#   3150 2249 1849 1480 1177 976 828 638 429 257 136 54                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 5039
Cumulative Months of Follow-Up 182831
Number of Leads Active in Study 2490
Information 30

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 5
Extra Cardiac Stimulation 2
Failure to Capture 6
Failure to Sense 2
Impedance Out of Range 4
Insulation (not further defined) 1
Lead Dislodgement 6
Oversensing 1
Other 2
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 268
Conductor Fracture 15
Extra Cardiac Stimulation 21
Failure to Capture 331
Failure to Sense 54
Impedance Out of Range 20
Insulation Breach 8
Lead Dislodgement 799
Oversensing 47
Unspecified Clinical Failure 31
Information

Distribution Data

US Market Release2000-08-31
CE Approval Date1999-08-12
Registered USA Implants1720845
Estimated Active USA Implants1089008
US Market Release2000-08-31
CE Approval Date1999-08-12
Estimated WW Distribution3192704
Information

USA Returned Product Analysis

Conductor Fracture 570
Insulation Breach 577
Crimp/Weld/Bond 0
Other 195
Information

WW Returned Product Analysis

Conductor Fracture 641
Insulation Breach 629
Crimp/Weld/Bond 0
Other 291
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 February 9, 2015

www.medtronic.com/productperformance 351052