6940 CapSureFix
Pacing
6940 CapSureFix
ALL
Information

Device Survival Probability


6940_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 99.7 99.5 98.2 98.0 98.0 98.0 98.0 98.0 98.0 98.0 94.2 92.8                  
#   621 505 416 342 271 210 189 152 123 91 72 57                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 834
Cumulative Months of Follow-Up 41556
Number of Leads Active in Study 77
Information 14

Qualifying Complications

Conductor Fracture 1
Failure to Capture 1
Failure to Sense 3
Lead Dislodgement 3
Oversensing 6
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Conductor Fracture 1
Failure to Capture 1
Impedance Out of Range 1
Lead Dislodgement 6
Information

Distribution Data

US Market Release1998-10-09
CE Approval Date
Registered USA Implants25385
Estimated Active USA Implants6934
US Market Release1998-10-09
CE Approval Date
Estimated WW Distribution31741
Information

USA Returned Product Analysis

Conductor Fracture 12
Insulation Breach 18
Crimp/Weld/Bond 0
Other 12
Information

WW Returned Product Analysis

Conductor Fracture 16
Insulation Breach 32
Crimp/Weld/Bond 0
Other 36
Information

Product Characteristics

Lead Type Pacing
Type and/or Fixation Active Screw-in
Lead Function Pacing/Sensing
Lead Placement Transvenous
Lead Tip Location Atrium - J
Pace/Sense Polarity Bipolar
More
Serial Number Prefix TCP
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 January 31, 2014

www.medtronic.com/productperformance 301050