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                
% Survival 99.5 99.3 99.2 98.9 98.9 98.4 98.1 97.6 97.0 97.0 96.5 96.5 95.5                
#   1653 1337 1021 683 557 457 362 292 231 187 145 93 53                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2346
Cumulative Months of Follow-Up 96740
Number of Leads Active in Study 645
Information 25

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 4
Failure to Capture 10
Failure to Sense 1
Impedance Out of Range 4
Lead Dislodgement 3
Oversensing 1
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 13 yr at 162.0 mo              
% Survival 99.6 99.5 99.4 99.2 98.9 98.7 98.6 98.5 98.5 98.4 98.4 98.1 98.1 98.1              
#   4962 3891 3021 2123 1652 1236 922 721 570 414 266 150 81 59              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 7272
Cumulative Months of Follow-Up 275934
Number of Leads Active in Study 3763
Information 46

Qualifying Complications

Cardiac Perforation 2
Conductor Fracture 8
Extra Cardiac Stimulation 2
Failure to Capture 8
Failure to Sense 2
Impedance Out of Range 4
Insulation (not further defined) 1
Lead Dislodgement 15
Oversensing 2
Other 2
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 600
Conductor Fracture 21
Extra Cardiac Stimulation 48
Failure to Capture 676
Failure to Sense 173
Impedance Out of Range 44
Insulation Breach 9
Lead Dislodgement 1760
Oversensing 136
Unspecified Clinical Failure 31
Information

Distribution Data

US Market Release2000-08-31
CE Approval Date1999-08-12
Registered USA Implants2133965
Estimated Active USA Implants1348691
US Market Release2000-08-31
CE Approval Date1999-08-12
Estimated WW Distribution4653655
Information

USA Returned Product Analysis

Conductor Fracture 750
Insulation Breach 749
Crimp/Weld/Bond 0
Other 205
Information

WW Returned Product Analysis

Conductor Fracture 845
Insulation Breach 810
Crimp/Weld/Bond 0
Other 309
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 3, 2017

www.medtronic.com/productperformance 476050