Medtronic CRM Product Performance Report

4512 Target Tip

    Product Characteristics
US Market Release Jul-83   Serial Number Prefix PF
Registered US Implants 10,300   Type and/or Fixation Transvenous, Atrial-J, Tines
Estimated Active US Implants 1,200   Polarity Bipolar
Advisories None   Steroid No

 

Atrial Placement    
System Longevity Study Results  
US Returned Product Analysis
Implant Damage 4
Electrical Malfunction 85
Other 8
Number of Leads Enrolled in Study 600
Cumulative Months of Follow-Up 39,833
Number of Leads Active in Study 4
     
Qualifying Complications 35 Total  
Electrical Abandonment 1  
Failure to Capture 6  
Failure to Sense 14  
Impedance Out of Range 3  
Insulation (ESC) 2  
Insulation (MIO) 4  
Insulation (not further defined) 2  
Lead Dislodgement 1  
Oversensing 2  
     

Survival Estimate of 4512 Target Tip Atrial Placement Leads