5554 CapSure Z Novus
Pacing
5554 CapSure Z Novus
ALL
Information

Device Survival Probability

5554_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr          
% Survival 100.0 98.2 97.1 95.9 95.9          
#   141 105 82 72 59          

Product Surveillance Registry Results

Number of Leads Enrolled in Study 352
Cumulative Months of Follow-Up 7717
Number of Leads Active in Study 38
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 29
Failure to Sense 2
Impedance Out of Range 1
Lead Dislodgement 31
Unspecified Clinical Failure 3
Information

Distribution Data

US Market Release1998-06-03
CE Approval Date1997-06-05
Registered USA Implants62851
Estimated Active USA Implants28845
US Market Release1998-06-03
CE Approval Date1997-06-05
Estimated WW Distribution226989
Information

USA Returned Product Analysis

Conductor Fracture 11
Insulation Breach 19
Crimp/Weld/Bond 0
Other 2
Information

WW Returned Product Analysis

Conductor Fracture 43
Insulation Breach 26
Crimp/Weld/Bond 0
Other 4
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 January 31, 2014

www.medtronic.com/productperformance 301050