5568 CapSureFix
Pacing
5568 CapSureFix
ALL
Information

Device Survival Probability

5568_SURV
Loading...











    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 99.4 98.8 98.8 98.8 98.0 97.1 97.1 95.9 95.9 95.9 95.9 92.9                  
#   558 455 378 303 244 195 152 128 106 85 66 51                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1152
Cumulative Months of Follow-Up 37384
Number of Leads Active in Study 131
Information 17

Qualifying Complications

Conductor Fracture 1
Extra Cardiac Stimulation 1
Failure to Capture 6
Failure to Sense 3
Lead Dislodgement 2
Oversensing 4
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 26
Failure to Sense 3
Impedance Out of Range 2
Insulation Breach 1
Lead Dislodgement 42
Oversensing 3
Unspecified Clinical Failure 4
Information

Distribution Data

US Market Release1997-01-02
CE Approval Date1996-08-14
Registered USA Implants96611
Estimated Active USA Implants45630
US Market Release1997-01-02
CE Approval Date1996-08-14
Estimated WW Distribution174060
Information

USA Returned Product Analysis

Conductor Fracture 20
Insulation Breach 43
Crimp/Weld/Bond 0
Other 38
Information

WW Returned Product Analysis

Conductor Fracture 21
Insulation Breach 44
Crimp/Weld/Bond 0
Other 94
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
Hide this content

Data as of November 2, 2015

www.medtronic.com/productperformance 376051