5534 CapSure Z
Pacing
5534 CapSure Z
ALL
Information

Device Survival Probability

5534_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr          
% Survival 97.7 96.9 96.9 95.9 95.9          
#   148 126 98 79 55          

Product Surveillance Registry Results

Number of Leads Enrolled in Study 267
Cumulative Months of Follow-Up 9578
Number of Leads Active in Study 4
Information 6

Qualifying Complications

Failure to Capture 5
Impedance Out of Range 1
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Extra Cardiac Stimulation 1
Failure to Capture 3
Failure to Sense 1
Lead Dislodgement 6
Unspecified Clinical Failure 4
Information

Distribution Data

US Market Release1996-02-09
CE Approval Date
Registered USA Implants25828
Estimated Active USA Implants6504
US Market Release1996-02-09
CE Approval Date
Estimated WW Distribution30759
Information

USA Returned Product Analysis

Conductor Fracture 5
Insulation Breach 5
Crimp/Weld/Bond 0
Other 4
Information

WW Returned Product Analysis

Conductor Fracture 9
Insulation Breach 7
Crimp/Weld/Bond 0
Other 7
Information

Product Characteristics

Lead Type Pacing
Type and/or Fixation Tines
Lead Function Pacing/Sensing
Lead Placement Transvenous
Lead Tip Location Atrium - J
Pace/Sense Polarity Bipolar
More
Serial Number Prefix LDG
Lead Body Diameter 7.8 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