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

Device Survival Probability

6933_6937_6937A_6963_SURV
Loading...











    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr at 114.0 mo                      
% Survival 99.2 99.2 99.2 98.3 95.5 93.4 92.3 91.0 88.4 88.4                      
#   117 115 112 107 95 83 76 70 57 52                      

Product Surveillance Registry Results

Number of Leads Enrolled in Study 124
Cumulative Months of Follow-Up 14124
Number of Leads Active in Study 6
Information 16

Qualifying Complications

Conductor Fracture 6
Failure to Capture 0
Impedance Out of Range 2
Insulation (not further defined) 2
Lead Dislodgement 1
Other 1
Unspecified Clinical Failure 4
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Conductor Fracture 3
Lead Dislodgement 1
Oversensing 2
Unspecified Clinical Failure 2
Information

Distribution Data

US Market Release2001-04-06
CE Approval Date
Registered USA Implants2999
Estimated Active USA Implants1553
US Market Release2001-04-06
CE Approval Date
Estimated WW Distribution4198
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
Hide this content

Data as of May 10, 2023

www.medtronic.com/productperformance 926050