4068 CapSureFix
Pacing
4068 CapSureFix
VENTRICULAR PLACEMENT
Information

Device Survival Probability


4068_VEN_SURV
    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr 10 yr 11 yr 12 yr                  
% Survival 99.2 98.5 98.5 97.8 97.4 96.5 95.1 93.4 90.0 89.1 87.1 84.9                  
#   1288 1110 964 802 666 529 410 316 228 149 91 58                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1806
Cumulative Months of Follow-Up 88693
Number of Leads Active in Study 107
Information 69

Qualifying Complications

Conductor Fracture 3
Extra Cardiac Stimulation 2
Failure to Capture 24
Failure to Sense 4
Impedance Out of Range 22
Insulation (not further defined) 1
Oversensing 10
Other 1
Unspecified Clinical Failure 2
ATRIAL PLACEMENT
Information

Device Survival Probability


4068_ATR_SURV
    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 at 174 mo            
% Survival 98.7 98.3 97.8 97.5 96.9 96.6 95.8 94.2 93.1 92.1 90.8 89.6 88.4 84.2 83.1            
#   1599 1392 1193 1016 873 737 586 482 398 323 241 173 122 74 54            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2425
Cumulative Months of Follow-Up 121983
Number of Leads Active in Study 196
Information 91

Qualifying Complications

Conductor Fracture 3
Extra Cardiac Stimulation 3
Failure to Capture 23
Failure to Sense 16
Impedance Out of Range 12
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 Implants124258
Estimated Active USA Implants29093
US Market Release1996-03-29
CE Approval Date
Estimated WW Distribution187348
Information

USA Returned Product Analysis

Conductor Fracture 51
Insulation Breach 180
Crimp/Weld/Bond 0
Other 93
Information

WW Returned Product Analysis

Conductor Fracture 64
Insulation Breach 185
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 January 31, 2014

www.medtronic.com/productperformance 301050