6996 Sub-Q Lead
Defibrillation
6996 Sub-Q Lead
ALL
Information

Device Survival Probability

6996_SURV
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    at 0.0 mo                  
% Survival 100.0                  
#   0                  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 44
Cumulative Months of Follow-Up 1338
Number of Leads Active in Study 17
Information 2

Qualifying Complications

Conductor Fracture 1
Other 1
Information

Advisories For This Model

  • There are no advisories for this model.

Performance Notes For This Model

Information

US Acute Lead Observations

Failure to Capture 1
Impedance Out of Range 5
Lead Dislodgement 1
Information

Distribution Data

US Market Release2001-06-11
CE Approval Date1997-12-19
Registered USA Implants4134
Estimated Active USA Implants2447
US Market Release2001-06-11
CE Approval Date1997-12-19
Estimated WW Distribution8146
Information

USA Returned Product Analysis

Conductor Fracture 24
Insulation Breach 0
Crimp/Weld/Bond 0
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 33
Insulation Breach 0
Crimp/Weld/Bond 0
Other 0
Information

Product Characteristics

Lead Type Defibrillation
Type and/or Fixation Suture on Anchor Sleeve
Lead Function Defibrillation Electrode
Lead Placement Subcutaneous
Lead Tip Location Defibrillation
Pace/Sense Polarity One Coil
More
Serial Number Prefix TCR
Lead Body Diameter 7.5 FR
Insulation Silicone
Pace/Sense Connector Style n/a
High Voltage Connector DF-1
Steroid None
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Data as of August 3, 2014

www.medtronic.com/productperformance 326050