6721 Epicardial Patch
Defibrillation
6721 Epicardial Patch
ALL
Information

Device Survival Probability

6721_6921_SURV
Loading...











    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr  
% Survival 96.5 94.5 91.9 90.8 89.0 84.2 82.8 82.8 82.8  
#   339 310 265 213 182 131 98 63 55  

Product Surveillance Registry Results

Number of Leads Enrolled in Study 408
Cumulative Months of Follow-Up 23386
Number of Leads Active in Study 3
Information 47

Qualifying Complications

Conductor Fracture 21
Failure to Capture 8
Impedance Out of Range 4
Insulation (not further defined) 2
Oversensing 12
Information

Advisories For This Model

  • There are no advisories for this model.

Performance Notes For This Model

Information

US Acute Lead Observations

Cardiac Perforation 1
Conductor Fracture 2
Failure to Sense 1
Impedance Out of Range 3
Oversensing 1
Information

Distribution Data

US Market Release1994-03-31
CE Approval Date1993-01-01
Registered USA Implants2928
Estimated Active USA Implants1116
US Market Release1994-03-31
CE Approval Date1993-01-01
Estimated WW Distribution4195
Information

USA Returned Product Analysis

Conductor Fracture 13
Insulation Breach 1
Crimp/Weld/Bond 0
Other 0
Information

WW Returned Product Analysis

Conductor Fracture 16
Insulation Breach 2
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 TBH, TBG, TBB
Lead Body Diameter S, M, L
Insulation Silicone
Pace/Sense Connector Style n/a
High Voltage Connector DF-1
Steroid None
Hide this content

Data as of August 3, 2014

www.medtronic.com/productperformance 326050