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 90.2 89.5 88.0 86.4 86.4 86.4              
#   1289 1110 964 802 666 532 421 330 262 196 129 86 60 52              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1806
Cumulative Months of Follow-Up 91664
Number of Leads Active in Study 78
Information 69

Qualifying Complications

Conductor Fracture 3
Extra Cardiac Stimulation 2
Failure to Capture 24
Failure to Sense 4
Impedance Out of Range 21
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 89.4 87.5 85.5 84.7            
#   1606 1396 1197 1018 873 737 586 486 401 341 281 210 148 99 58            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2429
Cumulative Months of Follow-Up 124610
Number of Leads Active in Study 170
Information 92

Qualifying Complications

Conductor Fracture 4
Extra Cardiac Stimulation 3
Failure to Capture 23
Failure to Sense 15
Impedance Out of Range 12
Insulation (ESC) 2
Insulation (MIO) 2
Insulation (not further defined) 2
Lead Dislodgement 8
Oversensing 18
Other 0
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 Implants124260
Estimated Active USA Implants27694
US Market Release1996-03-29
CE Approval Date
Estimated WW Distribution187366
Information

USA Returned Product Analysis

Conductor Fracture 53
Insulation Breach 207
Crimp/Weld/Bond 0
Other 93
Information

WW Returned Product Analysis

Conductor Fracture 67
Insulation Breach 215
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 February 9, 2015

www.medtronic.com/productperformance 351052