5568 CapSureFix
Pacing
5568 CapSureFix
ALL
Information

Device Survival Probability

5568_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 at 138.0 mo                  
% Survival 99.4 98.7 98.7 98.7 97.9 97.0 97.0 95.7 95.7 95.7 95.7 94.2                  
#   533 431 363 293 233 189 147 124 103 80 62 52                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1129
Cumulative Months of Follow-Up 35649
Number of Leads Active in Study 122
Information 17

Qualifying Complications

Conductor Fracture 1
Extra Cardiac Stimulation 1
Failure to Capture 6
Failure to Sense 3
Impedance Out of Range 0
Lead Dislodgement 2
Oversensing 4
Other 0
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 14
Extra Cardiac Stimulation 2
Failure to Capture 23
Failure to Sense 2
Impedance Out of Range 2
Insulation Breach 1
Lead Dislodgement 40
Oversensing 3
Unspecified Clinical Failure 4
Information

Distribution Data

US Market Release1997-01-02
CE Approval Date1996-08-14
Registered USA Implants95421
Estimated Active USA Implants50832
US Market Release1997-01-02
CE Approval Date1996-08-14
Estimated WW Distribution153973
Information

USA Returned Product Analysis

Conductor Fracture 17
Insulation Breach 42
Crimp/Weld/Bond 0
Other 37
Information

WW Returned Product Analysis

Conductor Fracture 18
Insulation Breach 43
Crimp/Weld/Bond 0
Other 95
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 LDN
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