6940 CapSureFix
Pacing
6940 CapSureFix
ALL
Information

Device Survival Probability

6940_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 at 150.0 mo                
% Survival 99.7 99.5 98.2 98.0 98.0 98.0 98.0 98.0 98.0 98.0 94.7 93.5 93.5                
#   635 510 421 346 278 218 189 153 126 96 80 69 59                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 841
Cumulative Months of Follow-Up 42929
Number of Leads Active in Study 48
Information 14

Qualifying Complications

Conductor Fracture 1
Failure to Capture 1
Failure to Sense 3
Impedance Out of Range 0
Lead Dislodgement 3
Oversensing 6
Other 0
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 Implants6642
US Market Release1998-10-09
CE Approval Date
Estimated WW Distribution31745
Information

USA Returned Product Analysis

Conductor Fracture 13
Insulation Breach 20
Crimp/Weld/Bond 0
Other 12
Information

WW Returned Product Analysis

Conductor Fracture 18
Insulation Breach 34
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 February 9, 2015

www.medtronic.com/productperformance 351052