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                
% Survival 99.5 99.3 99.2 99.0 98.8 98.3 98.1 97.5 96.9 96.9 96.5 96.5 95.7                
#   1692 1374 1107 750 582 473 376 295 232 197 151 100 58                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2405
Cumulative Months of Follow-Up 100861
Number of Leads Active in Study 656
Information 26

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 5
Failure to Capture 10
Failure to Sense 1
Impedance Out of Range 4
Lead Dislodgement 3
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 at 162.0 mo              
% Survival 99.6 99.6 99.5 99.2 98.9 98.6 98.6 98.4 98.4 98.3 98.3 98.1 98.1 98.1              
#   5424 4203 3378 2440 1797 1380 1022 741 580 456 301 187 94 71              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 7696
Cumulative Months of Follow-Up 303710
Number of Leads Active in Study 3822
Information 52

Qualifying Complications

Cardiac Perforation 2
Conductor Fracture 9
Extra Cardiac Stimulation 2
Failure to Capture 8
Failure to Sense 3
Impedance Out of Range 6
Insulation (not further defined) 1
Lead Dislodgement 15
Oversensing 3
Other 3
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 705
Conductor Fracture 21
Extra Cardiac Stimulation 54
Failure to Capture 790
Failure to Sense 232
Impedance Out of Range 54
Insulation Breach 9
Lead Dislodgement 2065
Oversensing 184
Unspecified Clinical Failure 31
Information

Distribution Data

US Market Release2000-08-31
CE Approval Date1999-08-12
Registered USA Implants2268673
Estimated Active USA Implants1459257
US Market Release2000-08-31
CE Approval Date1999-08-12
Estimated WW Distribution5047292
Information

USA Returned Product Analysis

Conductor Fracture 819
Insulation Breach 837
Crimp/Weld/Bond 0
Other 218
Information

WW Returned Product Analysis

Conductor Fracture 925
Insulation Breach 907
Crimp/Weld/Bond 0
Other 326
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 July 31, 2017

www.medtronic.com/productperformance 501050