Medtronic CRM Product Performance Report

4194 Attain OTW

    Product Characteristics
US Market Release Aug-04   Serial Number Prefix LFG
Registered US Implants 81,900   Type and/or Fixation Transvenous, Left Ventricular
Cardiac Vein, Distal Double Curve
Estimated Active US Implants 61,900   Polarity Bipolar
Advisories None   Steroid Yes

 

System Longevity Study Results  
US Returned Product Analysis
Conductor Fracture 1
Crimp/Weld/Bond 0
Insulation Breach 14
Extrinsic 102
Other 12
Number of Leads Enrolled in Study 610
Cumulative Months of Follow-Up 14,097
Number of Leads Active in Study 472
   
   
Qualifying Complications 7 Total
Failure to Capture 1
Lead Dislodgement 6

 

Survival Estimate of 4194 Attain Leads