5554 CapSure Z Novus
Pacing
5554 CapSure Z Novus
ALL
Information

Device Survival Probability

5554_SURV
Loading...











    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr at 78.0 mo      
% Survival 100.0 98.2 97.2 96.0 96.0 96.0 96.0      
#   155 119 94 82 65 53 50      

Product Surveillance Registry Results

Number of Leads Enrolled in Study 363
Cumulative Months of Follow-Up 8955
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
Information

Advisories For This Model

  • There are no advisories 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 Implants64538
Estimated Active USA Implants24075
US Market Release1998-06-03
CE Approval Date1997-06-05
Estimated WW Distribution253435
Information

USA Returned Product Analysis

Conductor Fracture 21
Insulation Breach 35
Crimp/Weld/Bond 0
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 57
Insulation Breach 44
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
Hide this content

Data as of April 11, 2019

www.medtronic.com/productperformance 651050