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 36
Cumulative Months of Follow-Up 3249
Number of Leads Active in Study 11
Information 2

Qualifying Complications

Conductor Fracture 1
Failure to Capture 0
Impedance Out of Range 0
Oversensing 1
Other 0
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 Implants17588
Estimated Active USA Implants9097
US Market Release2001-06-25
CE Approval Date2001-03-23
Estimated WW Distribution84652
Information

USA Returned Product Analysis

Conductor Fracture 14
Insulation Breach 16
Crimp/Weld/Bond 0
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 18
Insulation Breach 16
Crimp/Weld/Bond 0
Other 0
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 November 8, 2019

www.medtronic.com/productperformance 726050