4068 CapSureFix
Pacing
4068 CapSureFix
VENTRICULAR PLACEMENT
Information

Device Survival Probability

4068_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 99.2 98.5 98.5 97.8 97.4 96.8 95.2 93.4 90.3 89.6 88.1 85.4 85.4 85.4              
#   1292 1112 966 804 668 533 422 331 263 200 140 99 68 56              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1808
Cumulative Months of Follow-Up 92354
Number of Leads Active in Study 69
Information 71

Qualifying Complications

Conductor Fracture 3
Extra Cardiac Stimulation 2
Failure to Capture 24
Failure to Sense 5
Impedance Out of Range 22
Insulation (not further defined) 1
Oversensing 10
Other 2
Unspecified Clinical Failure 2
ATRIAL PLACEMENT
Information

Device Survival Probability

4068_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 15 yr            
% Survival 98.7 98.3 97.8 97.5 96.9 96.6 95.8 94.2 92.9 91.9 90.8 89.5 87.3 85.5 84.7            
#   1612 1397 1198 1021 874 737 586 486 402 342 289 230 159 103 65            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2430
Cumulative Months of Follow-Up 125607
Number of Leads Active in Study 156
Information 93

Qualifying Complications

Conductor Fracture 4
Extra Cardiac Stimulation 3
Failure to Capture 23
Failure to Sense 15
Impedance Out of Range 13
Insulation (ESC) 2
Insulation (MIO) 2
Insulation (not further defined) 2
Lead Dislodgement 8
Oversensing 18
Unspecified Clinical Failure 3
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 5
Conductor Fracture 3
Extra Cardiac Stimulation 1
Failure to Capture 23
Failure to Sense 5
Impedance Out of Range 2
Insulation Breach 1
Lead Dislodgement 31
Unspecified Clinical Failure 4
Information

Distribution Data

US Market Release1996-03-29
CE Approval Date
Registered USA Implants124288
Estimated Active USA Implants22704
US Market Release1996-03-29
CE Approval Date
Estimated WW Distribution194932
Information

USA Returned Product Analysis

Conductor Fracture 54
Insulation Breach 216
Crimp/Weld/Bond 0
Other 94
Information

WW Returned Product Analysis

Conductor Fracture 68
Insulation Breach 225
Crimp/Weld/Bond 1
Other 244
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 LCE
Lead Body Diameter 7.2 FR
Insulation Polyurethane
Pace/Sense Connector Style IS-1 BI
High Voltage Connector n/a
Steroid Yes
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Data as of November 2, 2015

www.medtronic.com/productperformance 376051