5568 CapSureFix
Pacing
5568 CapSureFix
ALL
Information

Device Survival Probability


5568_SURV
    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr 10 yr 11 yr                    
% Survival 99.5 98.8 98.8 98.8 98.4 97.4 97.4 96.0 96.0 96.0 96.0                    
#   489 404 339 272 227 184 141 121 102 78 57                    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1082
Cumulative Months of Follow-Up 33206
Number of Leads Active in Study 108
Information 13

Qualifying Complications

Conductor Fracture 1
Extra Cardiac Stimulation 1
Failure to Capture 6
Failure to Sense 2
Lead Dislodgement 1
Oversensing 2
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 10
Extra Cardiac Stimulation 2
Failure to Capture 21
Failure to Sense 2
Impedance Out of Range 2
Insulation Breach 1
Lead Dislodgement 35
Oversensing 2
Unspecified Clinical Failure 4
Information

Distribution Data

US Market Release1997-01-02
CE Approval Date1996-08-14
Registered USA Implants93265
Estimated Active USA Implants50937
US Market Release1997-01-02
CE Approval Date1996-08-14
Estimated WW Distribution149400
Information

USA Returned Product Analysis

Conductor Fracture 14
Insulation Breach 30
Crimp/Weld/Bond 0
Other 37
Information

WW Returned Product Analysis

Conductor Fracture 15
Insulation Breach 31
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 January 31, 2014

www.medtronic.com/productperformance 301050