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 at 162.0 mo              
% Survival 99.5 99.3 99.2 99.0 98.8 98.3 98.1 97.6 97.1 97.1 96.7 96.7 96.0 96.0              
#   1785 1448 1191 968 755 520 415 320 237 198 164 123 84 68              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2819
Cumulative Months of Follow-Up 112827
Number of Leads Active in Study 869
Information 29

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 6
Failure to Capture 11
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 at 174.0 mo            
% Survival 99.6 99.5 99.4 99.1 98.8 98.6 98.4 98.2 98.2 98.1 98.0 97.8 97.8 97.4 97.4            
#   6444 5191 4029 3184 2432 1648 1232 896 628 472 370 274 164 90 64            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 8774
Cumulative Months of Follow-Up 370123
Number of Leads Active in Study 4063
Information 68

Qualifying Complications

Cardiac Perforation 2
Conductor Fracture 11
Extra Cardiac Stimulation 2
Failure to Capture 12
Failure to Sense 5
Impedance Out of Range 6
Insulation (not further defined) 2
Lead Dislodgement 21
Oversensing 3
Other 4
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 956
Conductor Fracture 22
Extra Cardiac Stimulation 72
Failure to Capture 1147
Failure to Sense 414
Impedance Out of Range 101
Insulation Breach 10
Lead Dislodgement 2901
Oversensing 341
Unspecified Clinical Failure 26
Information

Distribution Data

US Market Release2000-08-31
CE Approval Date1999-08-12
Registered USA Implants2522836
Estimated Active USA Implants1683781
US Market Release2000-08-31
CE Approval Date1999-08-12
Estimated WW Distribution5800321
Information

USA Returned Product Analysis

Conductor Fracture 992
Insulation Breach 1027
Crimp/Weld/Bond 0
Other 175
Information

WW Returned Product Analysis

Conductor Fracture 1119
Insulation Breach 1122
Crimp/Weld/Bond 0
Other 218
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 April 11, 2019

www.medtronic.com/productperformance 651050