4574 CapSure Sense
Pacing
4574 CapSure Sense
ALL
Information

Device Survival Probability

4574_SURV
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    1 yr 2 yr at 30.0 mo              
% Survival 99.0 99.0 99.0              
#   295 101 63              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 595
Cumulative Months of Follow-Up 8472
Number of Leads Active in Study 440
Information 4

Qualifying Complications

Failure to Capture 1
Lead Dislodgement 3
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Conductor Fracture 1
Failure to Capture 19
Failure to Sense 8
Lead Dislodgement 43
Oversensing 1
Unspecified Clinical Failure 4
Information

Distribution Data

US Market Release2002-06-23
CE Approval Date2002-02-01
Registered USA Implants64562
Estimated Active USA Implants43087
US Market Release2002-06-23
CE Approval Date2002-02-01
Estimated WW Distribution321042
Information

USA Returned Product Analysis

Conductor Fracture 9
Insulation Breach 4
Crimp/Weld/Bond 0
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 12
Insulation Breach 4
Crimp/Weld/Bond 0
Other 0
Information

Product Characteristics

Lead Type Pacing
Type and/or Fixation J-shape, tines
Lead Function Pacing/Sensing
Lead Placement Transvenous
Lead Tip Location Atrium
Pace/Sense Polarity Bipolar
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Serial Number Prefix BBE
Lead Body Diameter 5.3 FR
Insulation Polyurethane (outer) Silicone (inner)
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