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 15 yr 16 yr 17 yr 18 yr      
% Survival 99.5 99.3 99.2 99.1 98.9 98.6 98.3 98.0 97.6 97.6 97.3 97.3 96.9 95.7 95.7 95.7 95.7 95.7      
#   2222 1886 1560 1244 996 827 688 579 498 405 325 257 186 152 128 109 77 55      

Product Surveillance Registry Results

Number of Leads Enrolled in Study 3387
Cumulative Months of Follow-Up 162124
Number of Leads Active in Study 749
Information 35

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 7
Failure to Capture 13
Failure to Sense 1
Impedance Out of Range 4
Insulation (not further defined) 1
Lead Dislodgement 5
Oversensing 1
Other 2
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 16 yr 17 yr 18 yr 19 yr at 234.0 mo  
% Survival 99.6 99.5 99.3 99.1 98.8 98.7 98.5 98.3 98.3 98.3 98.2 98.0 97.7 97.4 97.2 97.2 96.9 96.9 96.9 96.9  
#   8441 6914 5877 4888 4079 3412 2727 2173 1773 1382 1086 874 673 521 420 335 223 142 84 65  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 13115
Cumulative Months of Follow-Up 608439
Number of Leads Active in Study 5396
Information 111

Qualifying Complications

Cardiac Perforation 2
Conductor Fracture 13
Extra Cardiac Stimulation 3
Failure to Capture 17
Failure to Sense 10
Impedance Out of Range 11
Insulation (not further defined) 3
Lead Dislodgement 41
Oversensing 3
Other 8
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 1621
Conductor Fracture 32
Extra Cardiac Stimulation 114
Failure to Capture 2387
Failure to Sense 1452
Impedance Out of Range 400
Insulation Breach 15
Lead Dislodgement 5159
Oversensing 800
Unspecified Clinical Failure 26
Information

Distribution Data

US Market Release2000-08-31
CE Approval Date1999-08-12
Registered USA Implants3285505
Estimated Active USA Implants1836408
US Market Release2000-08-31
CE Approval Date1999-08-12
Estimated WW Distribution8392358
Information

USA Returned Product Analysis

Conductor Fracture 1465
Insulation Breach 1574
Crimp/Weld/Bond 4
Other 205
Information

WW Returned Product Analysis

Conductor Fracture 1664
Insulation Breach 1713
Crimp/Weld/Bond 4
Other 250
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 December 1, 2023

www.medtronic.com/productperformance 951051