5068 CapSureFix
Pacing
5068 CapSureFix
VENTRICULAR PLACEMENT
Information

Device Survival Probability

5068_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                
% Survival 99.8 99.6 99.2 98.9 98.9 98.9 98.2 96.9 96.9 96.9 96.9 96.9 95.3                
#   454 364 293 247 222 188 151 126 105 89 73 61 54                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1373
Cumulative Months of Follow-Up 33497
Number of Leads Active in Study 35
Information 9

Qualifying Complications

Conductor Fracture 1
Extra Cardiac Stimulation 1
Failure to Capture 2
Impedance Out of Range 1
Insulation (not further defined) 2
Lead Dislodgement 1
Oversensing 1
ATRIAL PLACEMENT
Information

Device Survival Probability

5068_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                      
% Survival 99.3 99.3 98.9 98.9 98.9 98.9 98.9 96.2 96.2 96.2                      
#   364 316 265 229 196 156 129 99 66 56                      

Product Surveillance Registry Results

Number of Leads Enrolled in Study 985
Cumulative Months of Follow-Up 27702
Number of Leads Active in Study 24
Information 8

Qualifying Complications

Failure to Capture 3
Impedance Out of Range 1
Insulation (not further defined) 1
Lead Dislodgement 2
Oversensing 1
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 18
Conductor Fracture 4
Failure to Capture 31
Failure to Sense 5
Impedance Out of Range 1
Insulation Breach 1
Lead Dislodgement 20
Oversensing 1
Unspecified Clinical Failure 7
Information

Distribution Data

US Market Release1997-01-02
CE Approval Date
Registered USA Implants102344
Estimated Active USA Implants21102
US Market Release1997-01-02
CE Approval Date
Estimated WW Distribution136553
Information

USA Returned Product Analysis

Conductor Fracture 47
Insulation Breach 65
Crimp/Weld/Bond 2
Other 82
Information

WW Returned Product Analysis

Conductor Fracture 48
Insulation Breach 72
Crimp/Weld/Bond 2
Other 197
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 LDJ
Lead Body Diameter 7.2 FR
Insulation Silicone
Pace/Sense Connector Style IS-1 BI
High Voltage Connector n/a
Steroid Yes
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Data as of February 3, 2017

www.medtronic.com/productperformance 476050