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 98.7 98.2 98.0 97.5 96.9 96.9 96.6 96.6 95.9 95.9              
#   1750 1424 1173 928 658 505 404 307 236 198 163 119 73 59              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2675
Cumulative Months of Follow-Up 108782
Number of Leads Active in Study 785
Information 28

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 6
Failure to Capture 10
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 98.3 98.2 98.2 98.1 97.9 97.8 97.8 97.3 97.3            
#   6173 4839 3783 3014 2186 1553 1170 848 597 468 368 242 142 76 54            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 8394
Cumulative Months of Follow-Up 348981
Number of Leads Active in Study 3907
Information 65

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) 1
Lead Dislodgement 19
Oversensing 3
Other 4
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 866
Conductor Fracture 22
Extra Cardiac Stimulation 66
Failure to Capture 1020
Failure to Sense 351
Impedance Out of Range 77
Insulation Breach 9
Lead Dislodgement 2629
Oversensing 276
Unspecified Clinical Failure 31
Information

Distribution Data

US Market Release2000-08-31
CE Approval Date1999-08-12
Registered USA Implants2436342
Estimated Active USA Implants1607393
US Market Release2000-08-31
CE Approval Date1999-08-12
Estimated WW Distribution5535533
Information

USA Returned Product Analysis

Conductor Fracture 925
Insulation Breach 966
Crimp/Weld/Bond 0
Other 231
Information

WW Returned Product Analysis

Conductor Fracture 1043
Insulation Breach 1047
Crimp/Weld/Bond 0
Other 339
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 October 12, 2018

www.medtronic.com/productperformance 626050