4076 CapSureFix Novus
Pacing
4076 CapSureFix Novus
VENTRICULAR PLACEMENT
Information

Device Survival Probability

4076_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                  
% Survival 99.7 99.7 99.7 99.6 99.4 99.4 99.0 99.0 98.7 98.7 98.7 98.7                  
#   1346 1181 1050 894 716 561 443 352 266 149 113 59                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1654
Cumulative Months of Follow-Up 95308
Number of Leads Active in Study 470
Information 11

Qualifying Complications

Conductor Fracture 1
Extra Cardiac Stimulation 1
Failure to Capture 5
Impedance Out of Range 2
Lead Dislodgement 1
Other 1
ATRIAL PLACEMENT
Information

Device Survival Probability

4076_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 at 138.0 mo                  
% Survival 99.8 99.7 99.6 99.5 99.3 98.9 98.7 98.7 98.7 98.7 98.7 98.7                  
#   3056 2661 2297 1943 1532 1109 770 553 365 177 115 83                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 3798
Cumulative Months of Follow-Up 196650
Number of Leads Active in Study 1584
Information 25

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 2
Failure to Capture 8
Failure to Sense 3
Impedance Out of Range 0
Insulation (not further defined) 2
Lead Dislodgement 7
Oversensing 1
Other 1
Information

US Acute Lead Observations

Cardiac Perforation 142
Conductor Fracture 7
Extra Cardiac Stimulation 19
Failure to Capture 177
Failure to Sense 77
Impedance Out of Range 30
Insulation Breach 1
Lead Dislodgement 475
Oversensing 56
Unspecified Clinical Failure 10
Information

Distribution Data

US Market Release2004-02-25
CE Approval Date2004-06-14
Registered USA Implants641740
Estimated Active USA Implants448094
US Market Release2004-02-25
CE Approval Date2004-06-14
Estimated WW Distribution1420698
Information

USA Returned Product Analysis

Conductor Fracture 97
Insulation Breach 140
Crimp/Weld/Bond 1
Other 20
Information

WW Returned Product Analysis

Conductor Fracture 116
Insulation Breach 147
Crimp/Weld/Bond 1
Other 27
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 BBL
Lead Body Diameter 5.7 FR
Insulation Polyurethane/Silicone
Pace/Sense Connector Style IS-1 BI
High Voltage Connector n/a
Steroid Yes
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Data as of November 8, 2019

www.medtronic.com/productperformance 726050