6721 Epicardial Patch
Defibrillation
6721 Epicardial Patch
ALL
Information

Device Survival Probability

6721_6921_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr  
% Survival 96.6 94.6 92.1 91.0 89.3 84.7 83.3 83.3 83.3  
#   347 319 274 221 190 136 102 66 57  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 417
Cumulative Months of Follow-Up 24242
Number of Leads Active in Study 5
Information 51

Qualifying Complications

Conductor Fracture 21
Failure to Capture 8
Impedance Out of Range 4
Insulation (not further defined) 2
Other 16
Information

Customer Communications For This Model

  • There are no communications for this model.
Information

US Acute Lead Observations

Cardiac Perforation 1
Conductor Fracture 2
Failure to Capture 4
Failure to Sense 2
Impedance Out of Range 24
Oversensing 1
Information

Distribution Data

US Market Release1994-03-31
CE Approval Date1993-01-01
Registered USA Implants3434
Estimated Active USA Implants858
US Market Release1994-03-31
CE Approval Date1993-01-01
Estimated WW Distribution5606
Information

USA Returned Product Analysis

Conductor Fracture 15
Insulation Breach 1
Crimp/Weld/Bond 0
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 19
Insulation Breach 3
Crimp/Weld/Bond 0
Other 0
Information

Product Characteristics

Lead Type Defibrillation
Type and/or Fixation Suture
Lead Function Defibrillation Electrode
Lead Placement Epi Patch
Lead Tip Location Epicardial
Pace/Sense Polarity n/a
More
Serial Number Prefix TBB, TBG, TBH
Lead Body Diameter S, M, L
Insulation Silicone
Pace/Sense Connector Style n/a
High Voltage Connector DF-1
Steroid None
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Data as of May 24, 2025

www.medtronic.com/productperformance 1051050