4074 CapSure Sense
Pacing
4074 CapSure Sense
VENTRICULAR PLACEMENT
Information

Device Survival Probability


4074_VEN_SURV
    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr    
% Survival 99.6 99.4 99.4 99.4 99.4 99.4 98.8 98.8    
#   687 496 352 291 254 175 105 54    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1058
Cumulative Months of Follow-Up 34835
Number of Leads Active in Study 664
Information 5

Qualifying Complications

Conductor Fracture 1
Failure to Capture 1
Impedance Out of Range 2
Lead Dislodgement 1
ATRIAL PLACEMENT
Information

Device Survival Probability


4074_ATR_SURV
    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr    
% Survival 99.1 99.1 99.1 99.1 99.1 99.1 99.1 99.1    
#   201 191 183 167 149 120 90 61    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 214
Cumulative Months of Follow-Up 15498
Number of Leads Active in Study 132
Information 2

Qualifying Complications

Failure to Sense 1
Lead Dislodgement 1
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 11
Conductor Fracture 1
Failure to Capture 35
Failure to Sense 1
Impedance Out of Range 3
Lead Dislodgement 36
Information

Distribution Data

US Market Release2002-06-23
CE Approval Date2002-02-01
Registered USA Implants95673
Estimated Active USA Implants59537
US Market Release2002-06-23
CE Approval Date2002-02-01
Estimated WW Distribution465183
Information

USA Returned Product Analysis

Conductor Fracture 3
Insulation Breach 21
Crimp/Weld/Bond 0
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 6
Insulation Breach 21
Crimp/Weld/Bond 0
Other 8
Information

Product Characteristics

Lead Type Pacing
Type and/or Fixation Tines
Lead Function Pacing/Sensing
Lead Placement Transvenous
Lead Tip Location Right Ventricle
Pace/Sense Polarity Bipolar
More
Serial Number Prefix BBD
Lead Body Diameter 5.3 FR
Insulation Polyurethane (outer) Silicone (inner)
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