4076 CapSureFix Novus
Pacing
4076 CapSureFix Novus
VENTRICULAR PLACEMENT
Information

Device Survival Probability

4076_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
% Survival 99.8 99.8 99.8 99.7 99.4 99.4 99.0 99.0 98.5 98.5
#   1305 1153 1006 804 626 528 374 226 162 76

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1518
Cumulative Months of Follow-Up 84215
Number of Leads Active in Study 482
Information 9

Qualifying Complications

Conductor Fracture 1
Extra Cardiac Stimulation 1
Failure to Capture 3
Impedance Out of Range 2
Lead Dislodgement 1
Other 1
ATRIAL PLACEMENT
Information

Device Survival Probability

4076_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
% Survival 99.8 99.7 99.6 99.5 99.3 99.1 99.0 99.0 99.0 99.0
#   2725 2343 1940 1477 1044 757 490 251 165 73

Product Surveillance Registry Results

Number of Leads Enrolled in Study 3252
Cumulative Months of Follow-Up 153805
Number of Leads Active in Study 1545
Information 17

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 2
Failure to Capture 3
Failure to Sense 3
Insulation (not further defined) 2
Lead Dislodgement 5
Oversensing 1
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 94
Conductor Fracture 5
Extra Cardiac Stimulation 14
Failure to Capture 119
Failure to Sense 44
Impedance Out of Range 16
Insulation Breach 1
Lead Dislodgement 297
Oversensing 23
Unspecified Clinical Failure 12
Information

Distribution Data

US Market Release2004-02-25
CE Approval Date2004-06-14
Registered USA Implants564427
Estimated Active USA Implants385996
US Market Release2004-02-25
CE Approval Date2004-06-14
Estimated WW Distribution1204666
Information

USA Returned Product Analysis

Conductor Fracture 79
Insulation Breach 105
Crimp/Weld/Bond 1
Other 22
Information

WW Returned Product Analysis

Conductor Fracture 92
Insulation Breach 110
Crimp/Weld/Bond 1
Other 35
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 BBL
Lead Body Diameter 5.7 FR
Insulation Polyurethane/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