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 at 138.0 mo                  
% 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                  
#   483 397 309 267 232 191 164 137 103 83 64 51                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 987
Cumulative Months of Follow-Up 34168
Number of Leads Active in Study 31
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 at 174.0 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            
#   412 392 359 323 290 252 219 185 152 128 107 92 74 62 55            

Product Surveillance Registry Results

Number of Leads Enrolled in Study 426
Cumulative Months of Follow-Up 40141
Number of Leads Active in Study 49
Information 2

Qualifying Complications

Failure to Capture 1
Impedance Out of Range 0
Lead Dislodgement 1
Other 0
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 Implants98628
Estimated Active USA Implants31918
US Market Release1998-06-03
CE Approval Date1997-06-05
Estimated WW Distribution498944
Information

USA Returned Product Analysis

Conductor Fracture 15
Insulation Breach 43
Crimp/Weld/Bond 1
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 21
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 November 8, 2019

www.medtronic.com/productperformance 726050