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 94.6 93.4 93.4                
#   627 508 419 345 278 218 189 153 126 96 79 68 57                

Product Surveillance Registry Results

Number of Leads Enrolled in Study 839
Cumulative Months of Follow-Up 42597
Number of Leads Active in Study 64
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 Implants25383
Estimated Active USA Implants6847
US Market Release1998-10-09
CE Approval Date
Estimated WW Distribution31744
Information

USA Returned Product Analysis

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

WW Returned Product Analysis

Conductor Fracture 17
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 August 3, 2014

www.medtronic.com/productperformance 326050