5054 CapSure Z Novus
Pacing
5054 CapSure Z Novus
VENTRICULAR PLACEMENT
Information

Device Survival Probability

5054_VEN_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr 10 yr 11 yr                    
% Survival 99.3 99.1 99.1 98.7 98.7 97.3 97.3 97.3 97.3 97.3 97.3                    
#   477 389 302 260 226 188 163 136 95 68 51                    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 982
Cumulative Months of Follow-Up 32077
Number of Leads Active in Study 52
Information 9

Qualifying Complications

Failure to Capture 6
Failure to Sense 1
Impedance Out of Range 1
Lead Dislodgement 1
ATRIAL PLACEMENT
Information

Device Survival Probability

5054_ATR_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr 10 yr 11 yr 12 yr                  
% Survival 99.5 99.5 99.5 99.5 99.5 99.5 99.5 99.5 99.5 99.5 99.5 99.5                  
#   410 390 357 321 288 251 218 184 151 112 80 53                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 424
Cumulative Months of Follow-Up 36440
Number of Leads Active in Study 87
Information 2

Qualifying Complications

Failure to Capture 1
Lead Dislodgement 1
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 2
Conductor Fracture 1
Failure to Capture 23
Impedance Out of Range 3
Insulation Breach 1
Lead Dislodgement 29
Unspecified Clinical Failure 9
Information

Distribution Data

US Market Release1998-06-03
CE Approval Date1997-06-05
Registered USA Implants98885
Estimated Active USA Implants35509
US Market Release1998-06-03
CE Approval Date1997-06-05
Estimated WW Distribution488333
Information

USA Returned Product Analysis

Conductor Fracture 12
Insulation Breach 33
Crimp/Weld/Bond 1
Other 3
Information

WW Returned Product Analysis

Conductor Fracture 17
Insulation Breach 38
Crimp/Weld/Bond 1
Other 21
Information

Product Characteristics

Lead Type Pacing
Type and/or Fixation Tines
Lead Function Pacing/Sensing
Lead Placement Transvenous
Lead Tip Location Right Ventricle
Pace/Sense Polarity Bipolar
More
Serial Number Prefix LEH
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 2, 2015

www.medtronic.com/productperformance 376051