Medtronic CRM Product Performance Report

6721, 6921 Epicardial Patch

    Product Characteristics
US Market Release Feb-93   Serial Number Prefix TBH, TBG, TBB, TAD, TAC, or TAB
Registered US Implants 8,300   Type and/or Fixation Epicardial Defib Patch, Suture
Estimated Active US Implants 1,300   Polarity Defib Electrode only
Advisories None   Steroid No

 

System Longevity Study Results  
US Returned Product Analysis
Implant Damage 5
Electrical Malfunction 80
Other 0
Number of Leads Enrolled in Study 407
Cumulative Months of Follow-Up 18,283
Number of Leads Active in Study 12
   
Qualifying Complications 28 Total  
Conductor Fracture 20  
Failure to Capture 2  
Impedance Out of Range 3  
Insulation (not further defined) 3  
     

Survival Estimate of Epicardial Patch 6721, 6921