5033 CapSure Z
Pacing
5033 CapSure Z
ALL
Information

Device Survival Probability


5033_SURV
    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr 10 yr 11 yr 12 yr 13 yr 14 yr 15 yr at 186 mo          
% Survival 99.5 99.4 98.7 98.5 98.2 97.5 96.9 96.0 95.0 95.0 94.6 94.0 93.4 91.8 91.8 91.8          
#   902 761 672 584 510 436 379 326 276 233 194 159 136 104 75 58          

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1901
Cumulative Months of Follow-Up 75796
Number of Leads Active in Study 131
Information 31

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 8
Failure to Capture 15
Impedance Out of Range 4
Insulation (not further defined) 1
Lead Dislodgement 2
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Unspecified Clinical Failure 1
Information

Distribution Data

US Market Release1996-02-09
CE Approval Date
Registered USA Implants2340
Estimated Active USA Implants459
US Market Release1996-02-09
CE Approval Date
Estimated WW Distribution9279
Information

USA Returned Product Analysis

Conductor Fracture 1
Insulation Breach 0
Crimp/Weld/Bond 0
Other 3
Information

WW Returned Product Analysis

Conductor Fracture 2
Insulation Breach 1
Crimp/Weld/Bond 0
Other 5
Information

Product Characteristics

Lead Type Pacing
Type and/or Fixation Tines
Lead Function Pacing/Sensing
Lead Placement Transvenous
Lead Tip Location Right Ventricle
Pace/Sense Polarity Unipolar
More
Serial Number Prefix LDK
Lead Body Diameter 5.1 FR
Insulation Silicone
Pace/Sense Connector Style IS-1 UNI
High Voltage Connector n/a
Steroid Yes
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Data as of January 31, 2014

www.medtronic.com/productperformance 301050