5076 CapSureFix Novus
Pacing
5076 CapSureFix Novus
VENTRICULAR PLACEMENT
Information

Device Survival Probability

5076_VEN_SURV
Loading...











    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 98.7 98.2 98.0 97.5 96.9 96.9 96.4 96.4 95.7                
#   1715 1395 1137 840 596 485 395 298 234 198 159 109 64                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2522
Cumulative Months of Follow-Up 104025
Number of Leads Active in Study 720
Information 27

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 6
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
Loading...











    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 99.6 99.6 99.4 99.2 98.9 98.6 98.6 98.4 98.4 98.3 98.1 98.0 98.0 97.3              
#   5798 4469 3569 2739 1940 1463 1081 775 586 464 340 205 114 57              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 7984
Cumulative Months of Follow-Up 324408
Number of Leads Active in Study 3806
Information 56

Qualifying Complications

Cardiac Perforation 2
Conductor Fracture 10
Extra Cardiac Stimulation 2
Failure to Capture 8
Failure to Sense 4
Impedance Out of Range 6
Insulation (not further defined) 1
Lead Dislodgement 16
Oversensing 3
Other 4
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 788
Conductor Fracture 21
Extra Cardiac Stimulation 58
Failure to Capture 879
Failure to Sense 280
Impedance Out of Range 58
Insulation Breach 9
Lead Dislodgement 2303
Oversensing 218
Unspecified Clinical Failure 31
Information

Distribution Data

US Market Release2000-08-31
CE Approval Date1999-08-12
Registered USA Implants2346371
Estimated Active USA Implants1528342
US Market Release2000-08-31
CE Approval Date1999-08-12
Estimated WW Distribution5265491
Information

USA Returned Product Analysis

Conductor Fracture 873
Insulation Breach 904
Crimp/Weld/Bond 0
Other 223
Information

WW Returned Product Analysis

Conductor Fracture 988
Insulation Breach 976
Crimp/Weld/Bond 0
Other 331
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
Hide this content

Data as of January 31, 2018

www.medtronic.com/productperformance 601051