6933 SVC/CS
Defibrillation
6933 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 10 yr 11 yr                    
% Survival 98.4 97.5 97.2 96.7 95.4 94.9 93.9 93.4 92.2 91.1 91.1                    
#   820 689 576 484 388 312 219 170 111 73 50                    

Product Surveillance Registry Results

Number of Leads Enrolled in Study 966
Cumulative Months of Follow-Up 54184
Number of Leads Active in Study 12
Information 47

Qualifying Complications

Conductor Fracture 16
Extra Cardiac Stimulation 4
Failure to Capture 6
Failure to Sense 1
Impedance Out of Range 3
Insulation (not further defined) 2
Lead Dislodgement 1
Oversensing 10
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

Unspecified Clinical Failure 3
Information

Distribution Data

US Market Release1994-04-20
CE Approval Date
Registered USA Implants7978
Estimated Active USA Implants785
US Market Release1994-04-20
CE Approval Date
Estimated WW Distribution8518
Information

USA Returned Product Analysis

Conductor Fracture 105
Insulation Breach 15
Crimp/Weld/Bond 0
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 118
Insulation Breach 16
Crimp/Weld/Bond 0
Other 3
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 TAT
Lead Body Diameter 7.0 FR
Insulation Silicone
Pace/Sense Connector Style n/a
High Voltage Connector DF-1
Steroid None
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Data as of January 31, 2014

www.medtronic.com/productperformance 301050