6937A Transvene SVC-CS
Defibrillation
6937A Transvene SVC-CS
ALL
Information

Device Survival Probability

6933_6937_6937A_6963_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr at 114.0 mo                      
% Survival 99.1 99.1 99.1 98.2 95.3 94.3 93.1 91.8 89.0 89.0                      
#   117 113 110 104 92 82 76 69 55 50                      

Product Surveillance Registry Results

Number of Leads Enrolled in Study 122
Cumulative Months of Follow-Up 13652
Number of Leads Active in Study 11
Information 14

Qualifying Complications

Conductor Fracture 5
Failure to Capture 0
Impedance Out of Range 1
Insulation (not further defined) 2
Lead Dislodgement 1
Other 1
Unspecified Clinical Failure 4
Information

US Acute Lead Observations

Conductor Fracture 3
Unspecified Clinical Failure 2
Information

Distribution Data

US Market Release2001-04-06
CE Approval Date
Registered USA Implants2606
Estimated Active USA Implants1554
US Market Release2001-04-06
CE Approval Date
Estimated WW Distribution3679
Information

USA Returned Product Analysis

Conductor Fracture 5
Insulation Breach 0
Crimp/Weld/Bond 0
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 5
Insulation Breach 0
Crimp/Weld/Bond 0
Other 0
Information

Product Characteristics

Lead Type Defibrillation
Type and/or Fixation Passive
Lead Function Defibrillation Electrode
Lead Placement Transvenous
Lead Tip Location SVC/CS
Pace/Sense Polarity One Coil
More
Serial Number Prefix TDB
Lead Body Diameter 7.5 FR
Insulation Silicone with Polyurethane Overlay
Pace/Sense Connector Style n/a
High Voltage Connector DF-1
Steroid None
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Data as of November 8, 2019

www.medtronic.com/productperformance 726050