5554 CapSure Z Novus
Pacing
5554 CapSure Z Novus
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Information

Device Survival Probability

5554_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr      
% Survival 100.0 98.2 97.2 96.0 96.0 96.0 96.0      
#   156 120 94 82 66 55 51      

Product Surveillance Registry Results

Number of Leads Enrolled in Study 364
Cumulative Months of Follow-Up 9077
Number of Leads Active in Study 11
Information 5

Qualifying Complications

Failure to Capture 2
Impedance Out of Range 1
Lead Dislodgement 1
Oversensing 1
Other 0
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Conductor Fracture 1
Failure to Capture 31
Failure to Sense 2
Impedance Out of Range 1
Lead Dislodgement 38
Unspecified Clinical Failure 3
Information

Distribution Data

US Market Release1998-06-03
CE Approval Date1997-06-05
Registered USA Implants64426
Estimated Active USA Implants22429
US Market Release1998-06-03
CE Approval Date1997-06-05
Estimated WW Distribution253616
Information

USA Returned Product Analysis

Conductor Fracture 21
Insulation Breach 37
Crimp/Weld/Bond 0
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 58
Insulation Breach 46
Crimp/Weld/Bond 0
Other 2
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
More
Serial Number Prefix LEJ
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 April 10, 2020

www.medtronic.com/productperformance 751050