5594 CapSure SP Novus
Pacing
5594 CapSure SP Novus
ALL
Information

Device Survival Probability

5594_SURV
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    at 0.0 mo                  
% Survival 100.0                  
#   0                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 28
Cumulative Months of Follow-Up 2003
Number of Leads Active in Study 11
Information

Qualifying Complications

Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Failure to Capture 4
Lead Dislodgement 14
Unspecified Clinical Failure 2
Information

Distribution Data

US Market Release2001-06-25
CE Approval Date2001-03-23
Registered USA Implants17522
Estimated Active USA Implants9853
US Market Release2001-06-25
CE Approval Date2001-03-23
Estimated WW Distribution73337
Information

USA Returned Product Analysis

Conductor Fracture 12
Insulation Breach 12
Crimp/Weld/Bond 0
Other 1
Information

WW Returned Product Analysis

Conductor Fracture 16
Insulation Breach 12
Crimp/Weld/Bond 0
Other 1
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
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Serial Number Prefix LFD
Lead Body Diameter 6.0 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, 2016

www.medtronic.com/productperformance 451050