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 12 yr                  
% Survival 99.3 99.1 98.8 98.4 98.4 97.0 97.0 96.4 96.4 96.4 96.4 96.4                  
#   474 391 304 263 229 191 167 142 110 91 69 51                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 989
Cumulative Months of Follow-Up 34889
Number of Leads Active in Study 27
Information 11

Qualifying Complications

Failure to Capture 7
Failure to Sense 2
Impedance Out of Range 1
Lead Dislodgement 1
Other 0
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 13 yr 14 yr 15 yr at 186.0 mo          
% 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 99.5 99.5 99.5 99.5          
#   411 391 358 322 289 252 219 186 153 129 108 93 75 65 56 53          

Product Surveillance Registry Results

Number of Leads Enrolled in Study 426
Cumulative Months of Follow-Up 41161
Number of Leads Active in Study 41
Information 3

Qualifying Complications

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

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 2
Conductor Fracture 2
Failure to Capture 23
Impedance Out of Range 4
Insulation Breach 1
Lead Dislodgement 30
Unspecified Clinical Failure 9
Information

Distribution Data

US Market Release1998-06-03
CE Approval Date1997-06-05
Registered USA Implants98933
Estimated Active USA Implants19049
US Market Release1998-06-03
CE Approval Date1997-06-05
Estimated WW Distribution504585
Information

USA Returned Product Analysis

Conductor Fracture 16
Insulation Breach 43
Crimp/Weld/Bond 1
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 22
Insulation Breach 49
Crimp/Weld/Bond 1
Other 5
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 December 16, 2021

www.medtronic.com/productperformance 851050