Medtronic CRM Product Performance Report

4951, 4951M Spectraflex

    Product Characteristics
US Market Release Oct-81   Serial Number Prefix TF or LBJ
Registered US Implants 23,100   Type and/or Fixation Myocardial Stab-in, V or A, Peds
Estimated US Active Implants 2,200   Polarity Unipolar
Advisories None   Steroid No

 

System Longevity Study Results  
US Returned Product Analysis
Conductor Fracture 56
Crimp/Weld/Bond 0
Insulation Breach 39
Extrinsic 7
Other 29
Number of Leads Enrolled in Study 179
Cumulative Months of Follow-Up 4,494
Number of Leads Active in Study 4
     
Qualifying Complications 14 Total  
Conductor Fracture 1  
Failure to Capture 7  
Failure to Sense 3  
Impedance Out of Range 1  
Insulation (ESC) 1  
Insulation (not further defined) 1  
     

 

Survival Estimate of 4951, 4951M Spectraflex Leads