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 at 126.0 mo                    
% Survival 99.4 99.2 99.1 98.8 98.8 98.3 98.0 97.3 96.7 96.7 96.7                    
#   1026 840 694 561 480 399 322 238 144 92 71                    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1960
Cumulative Months of Follow-Up 65783
Number of Leads Active in Study 639
Information 19

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 4
Failure to Capture 6
Failure to Sense 1
Impedance Out of Range 4
Lead Dislodgement 2
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                    
% Survival 99.6 99.5 99.3 98.9 98.7 98.5 98.5 98.3 98.3 97.9 97.9                    
#   1962 1697 1481 1266 1094 925 757 512 310 177 71                    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 3733
Cumulative Months of Follow-Up 138160
Number of Leads Active in Study 1527
Information 27

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 3
Extra Cardiac Stimulation 2
Failure to Capture 6
Failure to Sense 2
Impedance Out of Range 4
Insulation (not further defined) 1
Lead Dislodgement 5
Oversensing 1
Other 2
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 187
Conductor Fracture 13
Extra Cardiac Stimulation 14
Failure to Capture 253
Failure to Sense 41
Impedance Out of Range 15
Insulation Breach 8
Lead Dislodgement 584
Oversensing 32
Unspecified Clinical Failure 31
Information

Distribution Data

US Market Release2000-08-31
CE Approval Date1999-08-12
Registered USA Implants1595428
Estimated Active USA Implants1004937
US Market Release2000-08-31
CE Approval Date1999-08-12
Estimated WW Distribution2862338
Information

USA Returned Product Analysis

Conductor Fracture 483
Insulation Breach 490
Crimp/Weld/Bond 0
Other 190
Information

WW Returned Product Analysis

Conductor Fracture 542
Insulation Breach 534
Crimp/Weld/Bond 0
Other 282
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 January 31, 2014

www.medtronic.com/productperformance 301050