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 96.6 96.6 96.6 96.6                    
#   480 391 302 260 225 187 161 136 97 71 53                    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 983
Cumulative Months of Follow-Up 32248
Number of Leads Active in Study 52
Information 10

Qualifying Complications

Failure to Capture 6
Failure to Sense 2
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                  
#   412 392 358 322 289 252 219 185 152 119 90 63                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 426
Cumulative Months of Follow-Up 37077
Number of Leads Active in Study 86
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 4
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 Implants99097
Estimated Active USA Implants35024
US Market Release1998-06-03
CE Approval Date1997-06-05
Estimated WW Distribution490464
Information

USA Returned Product Analysis

Conductor Fracture 13
Insulation Breach 35
Crimp/Weld/Bond 1
Other 3
Information

WW Returned Product Analysis

Conductor Fracture 18
Insulation Breach 40
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 April 14, 2016

www.medtronic.com/productperformance 426050