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              
% Survival 99.5 99.3 99.2 99.0 98.8 98.3 98.2 97.7 97.2 97.2 96.8 96.8 96.2 95.1              
#   1893 1474 1219 982 810 560 430 330 248 201 164 126 90 56              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2986
Cumulative Months of Follow-Up 117944
Number of Leads Active in Study 959
Information 30

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 6
Failure to Capture 12
Failure to Sense 1
Impedance Out of Range 4
Lead Dislodgement 4
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 14 yr 15 yr            
% Survival 99.6 99.5 99.4 99.1 98.8 98.6 98.4 98.3 98.3 98.1 98.0 97.9 97.9 97.5 97.5            
#   6749 5518 4363 3369 2657 1833 1313 972 686 478 372 289 182 109 62            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 9277
Cumulative Months of Follow-Up 395281
Number of Leads Active in Study 4294
Information 74

Qualifying Complications

Cardiac Perforation 2
Conductor Fracture 11
Extra Cardiac Stimulation 3
Failure to Capture 12
Failure to Sense 5
Impedance Out of Range 6
Insulation (not further defined) 2
Lead Dislodgement 26
Oversensing 3
Other 4
Information

US Acute Lead Observations

Cardiac Perforation 1069
Conductor Fracture 22
Extra Cardiac Stimulation 80
Failure to Capture 1288
Failure to Sense 495
Impedance Out of Range 135
Insulation Breach 11
Lead Dislodgement 3252
Oversensing 400
Unspecified Clinical Failure 26
Information

Distribution Data

US Market Release2000-08-31
CE Approval Date1999-08-12
Registered USA Implants2627903
Estimated Active USA Implants1755185
US Market Release2000-08-31
CE Approval Date1999-08-12
Estimated WW Distribution6130288
Information

USA Returned Product Analysis

Conductor Fracture 1061
Insulation Breach 1097
Crimp/Weld/Bond 0
Other 176
Information

WW Returned Product Analysis

Conductor Fracture 1203
Insulation Breach 1202
Crimp/Weld/Bond 0
Other 219
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 November 8, 2019

www.medtronic.com/productperformance 726050