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 10 yr at 126.0 mo                    
% Survival 98.4 97.5 97.2 96.7 95.4 94.9 93.9 93.4 92.2 91.1 91.1                    
#   827 696 582 489 390 314 218 168 109 71 56                    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 120
Cumulative Months of Follow-Up 13374
Number of Leads Active in Study 10
Information 14

Qualifying Complications

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

Advisories For This Model

  • There are no advisories for this model.

Performance Notes For This Model

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 Implants2478
Estimated Active USA Implants1476
US Market Release2001-04-06
CE Approval Date
Estimated WW Distribution3513
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 October 12, 2018

www.medtronic.com/productperformance 626050