5033 CapSure Z
Pacing
5033 CapSure Z
ALL
Information

Device Survival Probability

5033_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 12 yr 13 yr 14 yr 15 yr 16 yr          
% Survival 99.5 99.4 98.7 98.5 98.2 97.5 96.9 96.0 95.0 95.0 94.6 94.1 92.9 91.5 91.5 91.5          
#   902 761 672 584 510 436 379 326 276 236 197 169 146 118 100 62          

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1901
Cumulative Months of Follow-Up 77216
Number of Leads Active in Study 30
Information 32

Qualifying Complications

Cardiac Perforation 1
Conductor Fracture 8
Failure to Capture 16
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 Implants2339
Estimated Active USA Implants457
US Market Release1996-02-09
CE Approval Date
Estimated WW Distribution9280
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 August 3, 2014

www.medtronic.com/productperformance 326050