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 99.1 98.5 98.5 97.8 97.4 96.7 95.2 93.3 90.2 89.5 88.0 85.4 85.4 85.4              
#   1292 1112 965 802 667 532 419 329 262 207 146 105 74 60              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1808
Cumulative Months of Follow-Up 92660
Number of Leads Active in Study 63
Information 72

Qualifying Complications

Conductor Fracture 3
Extra Cardiac Stimulation 2
Failure to Capture 24
Failure to Sense 5
Impedance Out of Range 23
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 at 186.0 mo          
% 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 87.5 85.8 85.1 83.9          
#   1614 1401 1197 1018 873 732 582 484 402 348 293 240 173 110 73 57          

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2433
Cumulative Months of Follow-Up 126284
Number of Leads Active in Study 149
Information 94

Qualifying Complications

Conductor Fracture 4
Extra Cardiac Stimulation 3
Failure to Capture 23
Failure to Sense 16
Impedance Out of Range 14
Insulation (ESC) 2
Insulation (MIO) 2
Insulation (not further defined) 2
Lead Dislodgement 8
Oversensing 17
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 Implants124289
Estimated Active USA Implants22048
US Market Release1996-03-29
CE Approval Date
Estimated WW Distribution194938
Information

USA Returned Product Analysis

Conductor Fracture 56
Insulation Breach 222
Crimp/Weld/Bond 0
Other 93
Information

WW Returned Product Analysis

Conductor Fracture 70
Insulation Breach 231
Crimp/Weld/Bond 1
Other 243
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 April 14, 2016

www.medtronic.com/productperformance 426050