6932 Sprint
Defibrillation
6932 Sprint
ALL
Information

Device Survival Probability

6932_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 99.2 98.3 98.3 98.3 97.7 97.7 97.7 96.7 96.7 95.5 92.5 92.5                  
#   360 303 242 203 157 125 105 91 81 68 56 54                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 418
Cumulative Months of Follow-Up 25540
Number of Leads Active in Study 35
Information 11

Qualifying Complications

Extra Cardiac Stimulation 1
Failure to Capture 2
Failure to Sense 2
Impedance Out of Range 2
Oversensing 4
Information

US Acute Lead Observations

Failure to Capture 2
Failure to Sense 2
Impedance Out of Range 1
Lead Dislodgement 4
Unspecified Clinical Failure 2
Information

Distribution Data

US Market Release1996-08-06
CE Approval Date
Registered USA Implants14899
Estimated Active USA Implants4105
US Market Release1996-08-06
CE Approval Date
Estimated WW Distribution20112
Information

USA Returned Product Analysis

Conductor Fracture 23
Insulation Breach 26
Crimp/Weld/Bond 0
Other 2
Information

WW Returned Product Analysis

Conductor Fracture 54
Insulation Breach 39
Crimp/Weld/Bond 0
Other 8
Information

Product Characteristics

Lead Type Defibrillation
Type and/or Fixation Tines
Lead Function Pacing/Sensing and Defibrillation
Lead Placement Transvenous
Lead Tip Location Right Ventricle
Pace/Sense Polarity True Bipolar
More
Serial Number Prefix TCA
Lead Body Diameter 7.8 FR
Insulation Silicone
Pace/Sense Connector Style IS-1 BI
High Voltage Connector DF-1
Steroid Yes
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Data as of August 3, 2014

www.medtronic.com/productperformance 326050