4068 CapSureFix
Pacing
4068 CapSureFix
VENTRICULAR PLACEMENT
Information

Device Survival Probability

4068_VEN_SURV
Loading...











    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                
% Survival 99.2 98.5 98.5 97.8 97.4 96.8 95.2 93.4 90.2 89.5 87.9 86.2 86.2                
#   1288 1110 964 802 666 532 420 330 260 191 124 78 52                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1806
Cumulative Months of Follow-Up 91135
Number of Leads Active in Study 99
Information 68

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 1
Unspecified Clinical Failure 2
ATRIAL PLACEMENT
Information

Device Survival Probability

4068_ATR_SURV
Loading...











    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 174.0 mo            
% Survival 98.7 98.3 97.8 97.5 96.9 96.6 95.8 94.2 92.9 91.9 90.7 89.2 87.1 85.6 84.6            
#   1601 1394 1195 1016 873 737 586 484 399 334 269 191 134 91 66            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 2427
Cumulative Months of Follow-Up 123366
Number of Leads Active in Study 187
Information 91

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 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 Implants124226
Estimated Active USA Implants28664
US Market Release1996-03-29
CE Approval Date
Estimated WW Distribution187360
Information

USA Returned Product Analysis

Conductor Fracture 53
Insulation Breach 194
Crimp/Weld/Bond 0
Other 93
Information

WW Returned Product Analysis

Conductor Fracture 66
Insulation Breach 201
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
Hide this content

Data as of August 3, 2014

www.medtronic.com/productperformance 326050