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 96.3 96.3 96.3 96.3 96.3                  
#   473 390 303 262 228 190 166 140 108 89 69 51                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 988
Cumulative Months of Follow-Up 34569
Number of Leads Active in Study 26
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            
% 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            
#   411 391 358 322 289 252 219 186 153 129 108 93 75 64 56            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 426
Cumulative Months of Follow-Up 40806
Number of Leads Active in Study 43
Information 2

Qualifying Complications

Failure to Capture 1
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 Implants98930
Estimated Active USA Implants19128
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 48
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 October 11, 2021

www.medtronic.com/productperformance 826050