5034 CapSure Z
Pacing
5034 CapSure Z
VENTRICULAR PLACEMENT
Information

Device Survival Probability

5034_VEN_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr at 90.0 mo                          
% Survival 99.5 98.9 98.4 98.0 98.0 98.0 96.9 96.9                          
#   517 415 307 221 155 96 61 57                          

Product Surveillance Registry Results

Number of Leads Enrolled in Study 1213
Cumulative Months of Follow-Up 27981
Number of Leads Active in Study 12
Information 11

Qualifying Complications

Conductor Fracture 1
Failure to Capture 7
Failure to Sense 2
Lead Dislodgement 1
ATRIAL PLACEMENT
Information

Device Survival Probability

5034_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              
% Survival 99.5 99.5 99.5 99.5 99.5 99.5 98.8 98.8 98.8 98.8 98.8 98.2 97.2 97.2              
#   383 382 379 376 358 334 297 253 212 187 154 124 92 53              

Product Surveillance Registry Results

Number of Leads Enrolled in Study 386
Cumulative Months of Follow-Up 45682
Number of Leads Active in Study 110
Information 6

Qualifying Complications

Conductor Fracture 1
Failure to Capture 2
Failure to Sense 1
Impedance Out of Range 1
Other 1
Information

Advisories For This Model

  • There are no advisories for this model.
Information

US Acute Lead Observations

Cardiac Perforation 2
Conductor Fracture 2
Failure to Capture 28
Failure to Sense 3
Insulation Breach 3
Lead Dislodgement 14
Unspecified Clinical Failure 12
Information

Distribution Data

US Market Release1996-02-09
CE Approval Date
Registered USA Implants55423
Estimated Active USA Implants11937
US Market Release1996-02-09
CE Approval Date
Estimated WW Distribution69353
Information

USA Returned Product Analysis

Conductor Fracture 14
Insulation Breach 15
Crimp/Weld/Bond 0
Other 7
Information

WW Returned Product Analysis

Conductor Fracture 19
Insulation Breach 19
Crimp/Weld/Bond 0
Other 16
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 LDF
Lead Body Diameter 7.8 FR
Insulation Silicone
Pace/Sense Connector Style IS-1 BI
High Voltage Connector n/a
Steroid Yes
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Data as of January 31, 2014

www.medtronic.com/productperformance 301050